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Allergan’s Restasis Will Soon be Open to Generic Copycats After Ruling in Patent Case

October 18, 2017

Four patents for Allergan’s blockbuster dry eye drug Restasis were invalidated by a federal judge on Monday, potentially leaving the drug open to generic copies.

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Antihypertensive Drugs Don’t Fully Restore Microvascular Function

October 17, 2017 - According to Researchers at Lancaster University, standard treatments for high blood pressure may not be addressing damaging circulation issues in small blood vessels.

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New California Law Aims to Increase Transparency in Drug Pricing

October 11, 2017 - Under the new law, pharmaceutical and biotech companies will be required to give 60-days notice before increasing the price of a drug more than 16 percent over two years.

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Cardiovascular Imaging for Monitoring Safety: Visualizing Outcomes

Treatment Allocation in Randomized Trials: Challenges and Best Practices

Allergan Gains Another Approval for Botox Amid Patent Controversy Over Restasis

October 5, 2017 - Pharmaceutical company Allergan has just received another FDA approval for its blockbuster cosmetic product Botox.

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Aftermath of Brexit Could Cripple EMA

September 28, 2017 - A recent survey conducted by the European Medicines Agency (EMA) has found that as little as six percent of its staff would be willing to relocate once the regulatory body moves its headquarters out of London, England.

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Teva Names New CEO

September 13, 2017 - Israel-based pharmaceutical company Teva has announced that Kåre Schultz will replace Dr. Yitzhak Peterburg as President and CEO of the multinational.

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Johnson & Johnson Stops Hepatitis C Drug Development Program

September 12, 2017 - In the wake of Gilead’s string of hepatitis C therapy approvals, Johnson & Johnson’s pharmaceutical division, Janssen, has announced that it will cease development for the infectious disease.

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3,500 Job Cuts at Eli Lilly Signal Change in Focus

September 12, 2017 - Pharmaceutical company Eli Lilly has announced it will be implementing around 3,500 layoffs globally, in an effort to “streamline operations.”

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Novartis to See Change in Leadership in 2018

September 6, 2017 - Just one week after being the first biopharmaceutical company to be granted the US Food and Drug Administration (FDA) approval for a CAR-T immunotherapy, Novartis CEO Joseph Jimenez has announced he will be giving up his position in 2018.

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FDA Approves New Antibacterial for UTIs

August 31, 2017 - The Rempex Pharmaceuticals’ antibacterial drug, Vabomere, has been approved by the US Food and Drug Administration (FDA) to treat adults with complicated urinary tract infections (cUTI).

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FDA First: Adamas Parkinson’s Drug Approved for Dyskinesia

August 30, 2017 - The US Food and Drug Administration (FDA) has approved the first therapy for patients with Parkinson’s disease-associated dyskinesia.

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Cardiome Resubmission of Atrial Fibrillation Drug Application to FDA Uncertain

August 25, 2017 - The regulator refused to approve Brinavess (vernakalant hydrochloride, IV) and advised the drugmaker that their compiled data would be insufficient for a resubmission.

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Study: Cost-Effectiveness of PCSK9 Inhibitors Must be Improved for Better Patient Adoption

August 24, 2017 - According to a recent report published in JAMA, the price of Amgen’s PCSK9 drug, Repatha, would need to be significantly reduced in order to be a cost-effective treatment for some patients.

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FDA User Fee Act Reauthorization Signed into Law by President Trump

August 23, 2017 - The Food and Drug Administration (FDA) Reauthorization Act (FDARA) of 2017 was officially signed into law on Friday by President Donald Trump.

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Exploring the FDA’s Accelerated Approval Pathway

August 21, 2017 - Investigational new drugs that could fill an unmet medical need are sometimes granted “Accelerated Approval” by the US Food and Drug Administration (FDA) in an effort to make these medicines available to the patients who need them.

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Could Importing Prescription Drugs from Canada Solve the US Drug Pricing Issue?

August 15, 2017 - Senator Bernie Sanders introduced the Affordable and Safe Prescription Drug Importation Act in late February in an effort to provide US-based pharmacies with a legal route of importing less expensive branded pharmaceuticals from Canada.

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AbbVie’s 8-Week Hepatitis C Drug to Rival Gilead’s Bestselling Therapies

August 8, 2017 - The US Food and Drug Administration (FDA) has just approved AbbVie’s Mavyret (glecaprevir/pibrentasvir), the first treatment for hepatitis C to show a 98 percent cure rate in as little as eight weeks.

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760 New Genetic Drug Targets Identified by Cancer Researchers

July 28, 2017 - A new cancer dependency map, developed by researchers at the Broad Institute of MIT and Harvard, and the Dana-Farber Cancer Institute, has identified over 760 genes which could be potential drug targets for future anti-cancer therapies.

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Approved Alzheimer’s Drug Could Reduce Inflammation in Patients with Metabolic Syndrome

July 28, 2017 - A recent report published in the journal JCI Insight suggests that an existing Alzheimer’s drug could also be used to treat patients with metabolic syndrome, a condition characterized by high blood pressure, elevated glucose levels, high cholesterol and excess fat around the midline.

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Hydrogel Drug Delivery Could Improve Safety of Slow-Release Medications

July 27, 2017 - The hydrogel remains intact when exposed to the harsh conditions in the gastrointestinal tract, and can be triggered to release its drug payload using an external signal.

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Gilead’s Newest Hepatitis C Drug Gets FDA Approval

July 21, 2017 - Dominant player in the chronic hepatitis C virus (HCV) market Gilead has received US Food and Drug Administration (FDA) approval for its newest treatment, Vosevi.

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Eli Lilly Resolves Pending Patent Litigation for Best-Selling Cialis

July 14, 2017 - After going head-to-head with generic drugmakers in the US District Court for the Eastern District of Virginia, Eli Lilly has reached an agreement with the competitors regarding the impending patent expiration of its best-selling erectile dysfunction drug, Cialis (tadalafil).

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First New Treatment in Two Decades for Sickle Cell Disease Approved by FDA

July 11, 2017 - Emmaus Life Sciences’ sickle cell disease drug Endari (L-glutamine oral powder) has been approved by the US Food and Drug Administration (FDA).

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How Reproducible are Preclinical Study Results?

July 10, 2017 - According to McGill University researchers, cancer scientists often believe that preclinical study results can be replicated more often than they actually are.

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FDA Approves Shire’s New ADHD Drug

June 23, 2017 - No stranger to the ADHD market, Shire has announced that their new drug Mydayis (mixed salts of a single-entity amphetamine product) had been approved by the FDA.

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Teva’s Generic HIV Drug Gains FDA Approval

June 16, 2017 - The FDA has approved Teva Pharmaceutical’s generic version of Gilead’s HIV drug, Truvada.

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FDA Rejects Sunovion’s New Drug Application for COPD Medication

June 1, 2017 - Sunovion Pharmaceuticals has announced receipt of a Complete Response Letter (CRL) from the FDA in regards to their New Drug Application (NDA) for SUN-101/eFlow (glycopyrrolate), a drug developed for the maintenance of chronic obstructive pulmonary disease (COPD).

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Patients Show Improved Medication Adherence to HIV Drugs in Recent Years

May 30, 2017 - A recent study of Medicaid data in the US has found that HIV patients are adhering better to their disease management medications, compared to previous years.

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Researchers Urge FDA to Update Guidance for Alzheimer’s Drug Approvals

May 17, 2017 - Alzheimer’s disease drugs are notoriously difficult to develop, as they often show efficacy in early stage clinical trials but fail to meet critical endpoints when it comes to the pivotal Phase III study.

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FDA Approves First New ALS Drug in Two Decades

May 9, 2017 - The intravenous infusion treatment is the first to be approved to treat the rare disease in over 20 years.

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Two Drugs Being Tested To Prevent Cell Death in Dementia Patients

April 21, 2017 - Medical Research Council (MRC) scientists have repurposed two drugs to prevent neurodegeneration characteristic of dementia in mouse models.

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Observational Study Finds Sanofi’s Diabetes Drug Lowers Incidence of Hypoglycemia

April 4, 2017 - Data from a recent real-world observational study has found that that Sanofi’s type 2 diabetes drug, Toujeo (insulin glargine 300 Units/mL), was associated with a lower risk of hypoglycemia, compared to other basal insulins.

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Over-The-Counter Viagra Could Be Coming to a Pharmacy Near You

March 31, 2017 - The British Medicines and Healthcare Products Regulatory Agency (MHRA) is looking at making Viagra (sildenafil) available as an over-the-counter (OTC) medication in the UK.

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Study Finds Only Half of all UK Healthcare Professionals Report Pharma Perks

March 29, 2017 - According to a study conducted by research organization, RAND Europe, 55 percent of UK healthcare professionals who received payment or another perk from the pharmaceutical industry in 2015, disclosed that information to a publicly-accessible database.

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New PARP Inhibitor Drug Approved to Treat Women with Recurrent Ovarian Cancer

March 29, 2017 - The US Food and Drug Administration (FDA) has approved Zejula (niraparib) as a maintenance treatment for women with certain types of recurrent cancers, including epithelial ovarian, fallopian tube, and primary peritoneal cancer.

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FDA Approves New Drug for Parkinson’s Disease

March 23, 2017 - Newron Pharmaceuticals’ Xadago (safinamide) has been approved by the US Food and Drug Administration (FDA) as an add-on medication for patients with Parkinson’s disease.

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PTC to Acquire Marathon’s Recently Approved Duchenne Muscular Dystrophy Drug

March 17, 2017 - Amid a drug pricing controversy, PTC Therapeutics has agreed to buy Marathon Pharmaceuticals’ Duchenne muscular dystrophy (DMD) drug, Emflaza.

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FDA Advisory Committees Find Benefits of Endo’s Opioid Drug Don’t Outweigh Risks

March 17, 2017 - Advisory committees to the US Food and Drug Administration (FDA) have voted that the risk of abuse associated with Endo International’s opioid drug, Opana ER (oxymorphone hydrochloride extended release), outweighs its benefits.

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Trump Nominates Scott Gottlieb for FDA Commissioner Position

March 14, 2017 - Former Deputy Commissioner for Medical and Scientific Affairs of the US Food and Drug Administration (FDA), Scott Gottlieb, has been nominated by President Donald Trump to be the next head of the agency.

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First Drug for Frequent Nighttime Urination Approved By FDA

March 10, 2017 - Serenity Pharmaceuticals’ nasal spray, Noctiva, has been approved by the US Food and Drug Administration (FDA) to treat patients who experience frequent nighttime urination.

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FDA Approves Corticosteroid Drug to Treat Duchenne Muscular Dystrophy

February 13, 2017 - Just months after Sarepta Therapeutics’ Exondys 51 became the first US Food and Drug Administration (FDA) approved drug to treat Duchenne muscular dystrophy (DMD), the agency has approved Marathon Pharmaceuticals’ Emflaza (deflazacort).

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Over 150 Biotech Executives Sign Letter Against Trump’s Immigration Ban

February 10, 2017 - In a letter to the editor of the Nature Biotechnology Trade Secrets blog, 166 biotechnology executives have expressed their concern regarding President Donald Trump’s travel ban on those coming from seven Muslim countries.

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Trump’s Plans for Pharma Industry Gain Support of CEOs

February 2, 2017 - Though President Donald Trump’s remarks on controlling drug prices may have initially scared pharmaceutical companies, his newest plans are music to their ears.

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Japanese Asthma Drug Could Be Effective Treatment for Alcoholism

February 2, 2017 - A new study conducted by researchers at UCLA, has found that an asthma medication which is only approved in Japan could be an effective treatment option for patients struggling with alcoholism.

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Generic EpiPen Hits CVS Shelves at Just Over $100 for Two-Pack

January 16, 2017 - US pharmacy chain CVS has begun selling a generic version of Mylan’s EpiPen for about one sixth the price of the branded medicine.

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Humana and Boehringer Ingelheim Report New Findings on COPD Medication Adherence

January 10, 2017 - Healthcare insurance company, Humana, and global pharmaceutical company, Boehringer Ingelheim, have found an association between medication adherence to chronic obstructive pulmonary disease (COPD) treatments and other chronic disease drugs.

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Obama Signs 21st Century Cures Act Into Law

December 15, 2016 - This week, President Barack Obama signed the 21st Century Cures Act – a bill that promises additional funding for cancer research and opioid addiction prevention – into law.

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Sweden Joins Campaign for Post-Brexit Host of EMA

December 14, 2016 - Last week, the Swedish government joined the competition to become the new host country of the European Medicines Agency (EMA).

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Former Insys Therapeutics Executives Charged in Fentanyl Pushing Scheme

December 12, 2016 - While the opioid drug is only approved for the treatment of cancer pain, the executives are accused of paying doctors to prescribe the drug for other, unapproved indications.

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Pfizer Fined Nearly £90 Million for Epilepsy Drug Price Hike in UK

December 2, 2016 - If the bill is passed in the Senate – and it’s expected to – the National Institutes of Health (NIH) will receive an additional $4.8 billion in medical research funding.

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US House of Representatives Passes 21st Century Cures Act

December 2, 2016 - If the bill is passed in the Senate – and it’s expected to – the National Institutes of Health (NIH) will receive an additional $4.8 billion in medical research funding.

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Increasing Skin Permeability to Improve Drug Delivery

November 22, 2016 - Researchers from Shizuoka University in Japan have developed a method using atmospheric microplasma to disrupt this impermeable layer of the skin.

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Opioid Overdose Antidote Enantiomer Could Prevent Pre-Term Birth

November 21, 2016 - The research – which was published in the Nature journal, Scientific Reports – provides a more in-depth understanding of the inflammatory response that can lead to premature labour.

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Celebrex Has Similar Risk Profile to Other NSAIDs, Could Be Sold Over-The-Counter

November 16, 2016 - The results of the PRECISION study showed that Celebrex is as safe as the two other NSAIDs tested.

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Cempra’s Antibiotic Drug Close To Receiving FDA Approval

November 8, 2016 - An independent advisory panel to the US Food and Drug Administration (FDA), has voted 7-6 that the regulatory agency should approve Cempra’s antibiotic drug, solithromycin.

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Pfizer Discontinues Development of PCSK9 Inhibitor

November 2, 2016 - The company sites weak data and changes in the cholesterol-lowering drugs market, as the main reasons behind their decision to discontinue the development program.

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Biscayne Pharmaceuticals Posts Preclinical Study Data for Antiepileptic Drug

October 25, 2016 - Biscayne Pharmaceuticals have reported that their antiepileptic compound, BIS-001, was able to eliminate seizures in most animal models of a form of the disorder known as Dravet syndrome.

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Soft Tissue Sarcoma Drug Gets FDA Accelerated Approval

October 21, 2016 - Eli Lilly’s Lartruvo (olaratumab) has received accelerated approval from the US Food and Drug Administration (FDA), for the treatment of select types of soft tissue sarcoma.

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Catabasis Joins Sarepta To Develop Combination Therapy For DMD

October 3, 2016 - The two companies have announced a joint research project aimed at testing a combination therapy for the rare disease.

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Pfizer To Keep Branded And Generics Businesses Together

September 28, 2016 - After toying with the idea of separating their branded drugs and generics divisions, Pfizer has announced that it will remain one company.

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Post-Shkreli, Turing Pharmaceuticals Announces New Toxoplasmosis Drugs In Preclinical Development

September 23, 2016 - According to a press release issued on Wednesday, Turing Pharmaceuticals will be pushing several new drug candidates for toxoplasmosis into preclinical development.

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UPDATE: FDA Commissioner Calls For Retraction Of Duchenne Muscular Dystrophy Drug Study

September 23, 2016 - Just days after Sarepta Therapeutics’ eteplirsen became the first US Food and Drug Administration (FDA) approved treatment for Duchennemuscular dystrophy, the agency’s commissioner Dr. Robert Califf is calling for the drug study to be retracted.

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Will Pfizer's Potential Acquisition of Medivation Result in Lower Costs for Xtandi?

September 16, 2016 - XTandi is a second tier attack used for prostate cancer that has become resistant to androgen deprivation. It works by preventing receptors from recognizing their androgen ligand. Xtandi has been found to successfully improve survival in metastatic prostate cancer patients.

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Dual Phage/Antibiotic Therapy May Be a Way to Increase Longevity of Antibiotics

September 13, 2016 - AmpliPhi Biosciences Corporation has recently been granted a patent to treat antibiotic-resistant infections with a dual bacteriophage/antibiotic approach.

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Pfizer To Acquire Medivation in $14 Billion Deal

August 23, 2016 - Medivation has accepted Pfizer’s $14 billion bid to acquire the company, after a months-long process involving other bidders.

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New Drug Could Treat Trio Of Deadly Parasitic Infectious Diseases

August 10, 2016 - A new proteasome inhibitor drug could effectively treat three parasitic infections including, Chagas disease, leishmaniasis and sleeping sickness.

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Small Study Of Novartis Asthma Drug Shows Promising Results

August 9, 2016 - An experimental asthma medication developed by Novartis has shown promising results in a recent small investigational study.

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NHS Ordered To Cover Gilead’s HIV Drug In Court Ruling

August 5, 2016 - The pre-exposure prophylaxis (PrEP) drug – called Truvada – has a 92 percent success rate of preventing HIV infection in those individuals who are at-risk of being exposed to the virus.

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Teva And Allergan Finalize Generics Deal

August 2, 2016 - Last week, the Federal Trade Commission (FTC) approved the $40.5 billion acquisition of Allergan’s generic drugs business by Israel-based company, Teva Pharmaceuticals.

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Researchers Identify Multi-Action Drug Candidate For Type 2 Diabetes And Bone Disease

July 15, 2016 - Patients with type 2 diabetes face a significantly greater risk of bone fractures. Unfortunately, many drugs used to treat the condition further raise this risk – a side effect which limits the treatment options for postmenopausal diabetic women.

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Boehringer Ingelheim To Develop Cancer Drugs Aimed At Degrading Proteins

July 13, 2016 - “We are very excited to partner with Boehringer Ingelheim, one of the world's 20 leading pharmaceutical companies,” said Dr. Alessio Ciulli, Associate Professor of Chemical and Structural Biology at the University of Dundee.

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New Drug For Postpartum Depression On The Horizon

July 13, 2016 - Biotech company Sage Therapeutics has announced that their experimental postpartum depression drug was able to relieve symptoms in 70 percent of patients.

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GlaxoSmithKline and AstraZeneca Form Brexit Task Force

July 12, 2016 - Two leading British pharmaceutical companies, GlaxoSmithKline and AstraZeneca, have created a task force aimed at dealing with the fallout of Brexit.

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Bristol-Myers Squibb Acquires Swedish Biotech, Cormorant Pharmaceuticals

July 6, 2016 - In a deal worth just over $500 million, US pharmaceutical company Bristol-Myers Squibb has entered into an agreement to buy Sweden’s Cormorant Pharmaceuticals.

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Novartis’ Heart Drug Could Save 28,000 US Heart Failure Patients Each Year

June 28, 2016 - It’s estimated that 2.7 million patients in the US are affected by a specific type of heart failure – known as heart failure and reduced ejection fraction – and approximately 84 percent of this patient population could be candidates for treatment with Entresto.

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As Majority Vote In Favour Of Brexit, UK Pharmaceutical Industry Faces Uncertain Future

June 27, 2016 - In the wake of the UK’s decision to leave the EU – known as Brexit – Britain’s pharmaceutical industry is bracing for big changes in the market.

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Novo Nordisk’s Diabetes Drug Becomes Second Ever To Show Cardiovascular Benefit

June 16, 2016 - A recent clinical trial found that Novo Nordisk’s diabetes medication Victoza – an injectable GLP-1 receptor agonist – reduced the risk of cardiovascular episodes by 13 percent.

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Study Suggests Most Antidepressants Are Ineffective For Young Patients

June 10, 2016 - Many antidepressants are ineffective at treating children and young adults suffering from major depression, according to a recent meta-analysis of published data.

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US Senators Call For Drug Pricing Inquest Into Opioid Overdose Antidote

June 8, 2016 - Amid growing concerns over opioid abuse and addiction, two US senators are asking drugmakers to explain their pricing for the opioid overdose drug, naloxone.

AstraZeneca Licenses Gout Drug To Grünenthal For Up To $230 Million

June 6, 2016 - AstraZeneca continues to sell the rights to its gout drug, Zurampic, with German pharmaceutical company Grünenthal paying as much as $230 million for the rights in Europe and Latin America.

Daiichi Sankyo Abandons Phase III Clinical Trial Of Lung Cancer Drug

June 3, 2016 - The decision was based on a recommendation from an independent data monitoring committee which found the drug failed to be effective against non-small cell lung cancer.

Pain Paradox: Opioid Painkillers Prolong Chronic Pain In Rats

June 1, 2016 - A new study conducted by researchers at the University of Colorado Boulder, has found that opioids, like morphine, paradoxically increase the pain response in rats.

Jazz Pharmaceuticals Confirms Acquisition Of Celator

June 1, 2016 - The rumored deal between Jazz Pharmaceuticals and Celator has just been confirmed by the companies, with Jazz to acquire Celator for $1.5 billion.

FDA Approves First Medical Device Implant For Opioid Dependence

May 31, 2016 - The US Food and Drug Administration (FDA) has approved the first buprenorphine implantable medical device – marketed as Probuphine - for patients with opioid dependence.

First US Case Of Antibiotic Resistance To Last Resort Drug Signals Need For New Treatments

May 30, 2016 - According to a report issued on Thursday, the first patient to develop a bacterial infection that carries resistance to an antibiotic used to treat tough infections, has been identified in the US.

New Drug Manufacturing Technology Could Improve Personalized Medicine

May 27, 2016 - Engineers from the National University of Singapore (NUS), have developed a new way to manufacture personalized medicine that is less expensive and more convenient than currently-available methods.

Roche’s Immunotherapy Drug Wins FDA Approval

May 20, 2016 - Roche’s anti-PDL1 immunotherapy, atezolizumab, has become the first new drug in decades to be approved to treat the most common form of bladder cancer.

Proposed ‘Pay Or Play’ Deal To Encourage Antibiotic R&D In Pharmaceutical Industry

May 20, 2016 - A review conducted by the UK government recommends that pharmaceutical and biotech companies should be financially rewarded for investing in new antibiotics R&D.

Oramed’s Oral Insulin Clinical Trial Meets Primary Endpoint

May 19, 2016 - Looking to cash-in on the potentially $15 billion oral insulin market, Oramed is trying to beat Novo Nordisk to launch the first oral insulin product on the market.

AstraZeneca To Explore DNA Damage Drugs As Emerging Oncology Therapy

May 18, 2016 - Global biopharmaceutical company AstraZeneca is looking to expand their portfolio of cancer drugs that act on the DNA repair mechanisms in cells.

UPDATE: Valeant Releases Details On Hospital Discount Plan For Heart Drugs

May 18, 2016 - Amid criticism over Valeant’s failure to deliver on promised hospital discounts for two of their heart drugs, the company has released the details of its rebate program for Isuprel and Nitropress.

Cigna Makes Pricing Deals With Amgen, Sanofi For Cholesterol Drugs

May 13, 2016 - Cigna, a major US health insurer, has signed value-based pricing deals with the makers of two new PCSK9 cholesterol lowering drugs, Amgen and Sanofi.

India Upholds Gilead’s Patent For Hepatitis C Drug, Sovaldi

May 12, 2016 - After previously rejecting Gilead’s patent application for the hepatitis C drug, Sovaldi, the Indian Patent Office has reconsidered their decision by awarding a patent to the drugmaker.

Migraine Drugs May Be Underused Due To FDA-Mandated Black Box Warnings

May 11, 2016 - The results of the study suggest that these medications could be safe for a new subset of migraine sufferers, including the 10 million patients that experience migraine-associated changes in vision, touch, speech, thinking or strength, known as an aura.

Impax Laboratories Sues Turing Pharmaceuticals Over Breach Of Contract

May 9, 2016 - Earlier this week, Impax Laboratories asked a federal judge to stop Turing from selling the drug under their name.

Pfizer Considers Acquisition of Cancer Biotech, Medivation

May 5, 2016 - According to a report by Reuters, Pfizer has approached Medivation to discuss a possible takeover deal.

First Drug To Treat Parkinson’s Disease Psychosis Approved By The FDA

May 3, 2016 - A drug made by California-based biopharmaceutical company Acadia Pharmaceuticals, has become the first US Food and Drug Administration (FDA) approved treatment for psychosis linked to Parkinson’s disease.

Injectable Multiple Sclerosis Drug Passes EMA Regulatory Review

May 3, 2016 - The European Medicines Agency (EMA) has recommended Biogen and AbbVie’s injectable multiple sclerosis drug for marketing approval.

HIV Drugmaker Switches From Batch To Continuous Manufacturing

April 18, 2016 - For the first time, the US Food and Drug Administration (FDA) has approved a drugmaker’s decision to switch from traditional batch manufacturing to a continuous manufacturing process.

Generic Drug Could Reverse Vision Loss Due To Multiple Sclerosis

April 15, 2016 - In a mid-stage trial, patients taking the antihistamine showed improved eye-to-brain signaling, compared to those on the placebo.

FDA Approves AbbVie’s Drug For Rare Leukemia

April 13, 2016 - The US Food and Drug Administration (FDA) has approved AbbVie’s Venclexta as a second-line treatment for chronic lymphocytic leukemia, in patients with a chromosomal abnormality known as a 17p deletion.

AstraZeneca and Eli Lilly Pursue Late-Stage Clinical Trial For Alzheimer’s Drug

April 11, 2016 - Pharmaceutical powerhouses AstraZeneca and Eli Lilly have announced that they will be pushing their experimental Alzheimer’s candidate into a Phase III clinical trial.

FDA Approves Celltrion’s Remicade Biosimilar

April 11, 2016 - Celltrion’s Inflectra – a biosimilar to Janssen Biotech’s Remicade – is the second biosimilar to be approved by the US Food and Drug Administration (FDA).

Allergan Pays $3.3 Billion For The Rights To Heptares’ Alzheimer’s Drugs

April 8, 2016 - Allergan isn’t dwelling on the termination of its $160 billion merger with Pfizer; the biotech just acquired the global rights to Heptares’ neurological drugs portfolio.

Pfizer and Allergan Scrap Megamerger Deal

April 7, 2016 - The companies made the decision to scrap their $152 billion agreement following the US Treasury Department’s proposed regulations aimed at reducing the advantages of such an international merger.

Extended-Release Pill Attaches To GI Lining For Prolonged Drug Delivery

April 7, 2016 - Once swallowed, one side of the tablet binds to the intestinal tissue, while the other resists passing food and liquids which could dislodge it from its point of attachment.

Protein-Rich Frog Foam For Antibiotic Drug Delivery

March 24, 2016 - Scientists from the University of Strathclyde in Scotland, have demonstrated the effectiveness of a proteinaceous foam made by Tungara frogs, as an antibiotic delivery system for infection prevention.

Amgen Wins First Court Battle Over PCSK9 Patent Against Sanofi and Regeneron

March 18, 2016 - A US court jury ruled that Sanofi and Regeneron’s PCSK9 drug – sold as Praluent – infringed upon Amgen’s patent for its similar pharmaceutical, Repatha.

Bipolar Disorder Drug Market On Decline Due To Availability Of Generics

March 4, 2016 - According to research and consulting firm, GlobalData, the market value for bipolar disorder treatments is projected to drop by 28 percent to $4.2 billion, by 2024.

Sandoz Recalls Hypertension Drug Made At Indian Mylan Facility

February 29, 2016 - A Mylan-owned pharmaceutical manufacturing facility in India has run into more issues, leading to a voluntary recall of over 277,000 bottles of hypertension medication.

India’s Cipla Acquires First US Pharmaceutical Manufacturing Facility

February 22, 2016 - Global pharmaceutical company Cipla, has acquired two generic pharmaceutical manufacturing companies based in the US.

Type 2 Diabetes Drug May Prevent Heart Attack and Stroke

February 19, 2016 - A drug used to treat Type 2 diabetes – pioglitazone – may be effective at preventing recurrent heart attack and stroke, in patients who have some insulin resistance, but are not diabetic.

GlaxoSmithKline Receives $54.4 Million Fine In UK For Pay-For-Delay Deal

February 17, 2016 - According to a statement released by the UK’s Competition and Markets Authority (CMA) on Friday, the agency has fined GlaxoSmithKline for a pay-for-delay deal made over 10 years ago.

New LIGHTSABR Platform Could Streamline Drug Discovery

February 16, 2016 - In an attempt to improve drug discovery methods, researchers at The Scripps Research Institute (TSRI) have developed a novel screening system that would be both smaller and cheaper than previous methods.

The Surprising Link Between Vaccine Shortages And Price Per Dose

February 11, 2016 - Providing a reliable supply of a vaccine is dependent on a number of factors, including raw materials availability, quality control and supply chain and logistics.

FDA: Celltrion’s Remicade Biosimilar “Highly Similar” To Branded Drug

February 9, 2016 - According to US Food and Drug Administration (FDA) documents, the agency is in favour of Celltrion’s biosimilar of Johnson & Johnson’s Remicade.

Generic OxyContin On Horizon As Patents Don’t Hold Up In Court

February 4, 2016 - Purdue Pharma-held patents for its popular painkiller, OxyContin, have been invalidated based on a US Federal Circuit Court of Appeals ruling on Monday.

More Woes For Indian Pharma As FDA Alleges Wockhardt Concealed Failed Tests

February 2, 2016 - According to a report constructed by the US Food and Drug Administration (FDA), Indian pharmaceutical company Wockhardt concealed the results of failed tests and discarded data at its manufacturing facility in Western India.

Pfizer’s Lyrica Recalled Due To Heat Damage

February 1, 2016 - Pfizer has recalled almost 150,000 bottles of Lyrica – a best-seller used to treat nerve pain – after learning that the pharmaceuticals may have been exposed to extreme heat during transportation, leading to damage.

Generics Kept From Market In Favour Of High-Priced Brand-Name Drugs

January 29, 2016 - According to an article published in the American Society of Hematology journal, Blood, pharmaceutical companies are engaging in practices designed to prevent affordable, generic version of drugs off the market.

Off-Label Use Of Avastin Prompts Investigation By Roche

January 28, 2016 - Fifteen patients in India were hospitalized with vision problems last week after taking Roche’s cancer drug, Avastin, for off-label treatment of macular degeneration.

Over 80 Pharmaceutical Companies Join Forces For Antibiotics R&D

January 26, 2016 - During the World Economic Forum in Switzerland last week, over 80 pharmaceutical companies – including major players like GlaxoSmithKline, Pfizer and Merck – pledged to devote more resources to the development of new antibiotics.

New Drug May Stop Cancer-Causing Epstein-Barr Virus

January 21, 2016 - Researchers at Duke University have found that the drug rapamycin may be effective at controlling cell division of B cells infected with the Epstein-Barr virus.

Diabetes Drug Metformin Could Inhibit Progression of Pancreatic Cancer

January 19, 2016 - Researchers at Massachusetts General Hospital believe they have identified the mechanism behind diabetes drug metformin’s ability to stop the progression of pancreatic cancer.

Bayer Opens Manufacturing Facility In China For OTC Drugs

January 18, 2016 - Last week, German pharmaceutical giant, Bayer, opened a manufacturing plant in China, where both traditional Chinese medicines and Western over-the-counter (OTC) drugs, will be made.

Dr. Robert Califf Approved By Senate Panel As FDA Commissioner

January 15, 2016 - Back in September of 2015, President Barack Obama named Dr. Robert Califf – a respected cardiologist and researcher – as his nomination for the Food and Drug Administration (FDA) Commissioner.

Multi- Drug Microcapsules Could Improve Chemotherapy Drug Delivery

January 14, 2016 - Researchers from Ohio State University in the US and the University of Science and Technology of China have developed tiny capsules capable of keeping two cancer drug ingredients separated until they are triggered by a signal to mix at the site of a tumor

Arthritis Drug Could Prove Useful In Treating BRCA1-Positive Ovarian Cancer

January 13, 2016 - According to a study led by researchers at the University of Plymouth in the UK, a drug used to treat rheumatoid arthritis – called auranofin – could improve patient outcomes for women with ovarian cancer with a BRCA1 mutation.

Johnson & Johnson Announces New Collaborations And Seeks Hepatitis B Cure

January 12, 2016 - In anticipation of the 33rd annual J.P. Morgan Healthcare Conference, Johnson & Johnson will be announcing 21 new collaborations covering experimental disease treatments, medical devices and consumer health products.

Charles River Announces Acquisition of WIL Research

January 8, 2016 - Early yesterday, contract research organization (CRO) Charles River Laboratories announced they had entered into an agreement to acquire WIL Research for an estimated $585 million

Indian Pharmaceutical Manufacturer, Cadila, Receives FDA Warning Letter

January 6, 2016 - Cadila Healthcare is the latest to receive a warning letter from the agency for activities conducted at the company’s plants in Moraiya and Ahmedabad, though as of yet it’s unknown exactly what issues were identified at the facilities.

KaloBios Files For Bankruptcy Following Martin Shkreli’s December Arrest

January 5, 2016 - Now that Shkreli is facing up to 20 years in prison for allegedly committing securities fraud, KaloBios’ revival was short- lived as they file for Chapter 11.

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