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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.

Featured In: Biotech News, Pharmaceutical News

CRISPR Helps Researchers Design More Representative Preclinical Cancer Models

October 10, 2017 - New research published in the journal Cell Stem Cell suggests that multiplex CRISPR-Cas9 could be used to generate mouse models of disease which could be a more accurate predictor of the human response to a drug.

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New Guidelines Address CAR-T Immunotherapy Toxicities to Prevent Patient Deaths

September 20, 2017 - Clinicians at The University of Texas MD Anderson Cancer Center have published new guidelines in the journal, Nature Reviews Clinical Oncology, which could help in the management of these toxicities.

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Avastin Biosimilar Becomes First FDA-Approved Copy-Cat for Cancer

September 18, 2017 - In an historic event, the US Food and Drug Administration (FDA) has approved a biosimilar version of Roche’s cancer treatment Avastin (bevacizumab).

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First CAR-T Cell Immunotherapy Approved in US Signals Paradigm Shift in Cancer Treatment

September 1, 2017 - Novartis’ Kymriah (tisagenlecleucel) is indicated for the treatment of pediatric and young adult patients with refractory or relapsed acute lymphoblastic leukemia (ALL).

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Pharma Competitive Intelligence: Delivering Actionable Insights for Decision Making

Electronic Informed Consent: 2017 Industry Survey Results from Clinical Sites

Gilead to Acquire Kite Pharma for $11.9 Billion in Immunotherapy Deal

August 29, 2017 - Biopharmaceutical company Gilead Sciences announced on Monday that it would be buying cancer immunotherapy business Kite Pharma in a deal worth $11.9 billion.

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Samsung Bioepis and Takeda to Co-Develop Novel Biologic Drugs

August 22, 2017 - Biosimilars drugmaker Samsung Bioepis has joined forces with Takeda Pharmaceutical to develop biologic therapies in novel disease areas.

Featured In: Biotech News

Type 1 Diabetes Could Eventually Be Treated Using Immunotherapy

August 11, 2017 - Researchers at the Cardiff University School of Medicine have found that an immunotherapy designed to treat diabetes was both safe and effective when tested in a small clinical trial.

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Researchers Use CRISPR to Repair Inherited Mutation Which Causes Cardiac Condition

August 8, 2017 - Using CRISPR gene editing, researchers at Oregon Health & Science University have successfully repaired a heart disease-causing mutation that can contribute to heart failure and sudden cardiac death.

Featured In: Biotech News

FDA Approves Celgene’s AML Treatment Paired with Abbott’s Companion Diagnostic

August 4, 2017 - Patients with acute myeloid leukemia (AML), an aggressive form of blood cancer, could now have a new treatment option thanks to the US Food and Drug Administration’s (FDA) approval of Celgene’s Idhifa (enasidenib).

Featured In: Biotech News, Medical Device News

Johnson & Johnson Debuts New DTC Crohn’s Disease Ad for Stelara

August 3, 2017 - J&J subsidiary Janssen, has released a new direct-to-consumer (DTC) ad promoting Stelara’s latest indication in the treatment of Crohn’s disease.

Featured In: Biotech News, Pharmaceutical Marketing News

Long-Acting Antiretroviral Therapy to Reduce Pill Burden on HIV Patients

July 25, 2017 - Researchers from the University of North Carolina have shown that a monthly ART injection could be as effective – or even more effective – compared to standard ART at preventing HIV from once again becoming infectious.

Featured In: Biotech News

New Self-Injectable Form of Lupus Drug Approved by the FDA

July 25, 2017 - Patients with systemic lupus erythematosus (SLE) will now have the option to self-inject their medication thanks to the FDA approval of GSK’s reformulated lupus drug, Benlysta (belimumab).

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Detecting Alzheimer’s Biomarkers in the Blood Could Improve Early Diagnosis

July 20, 2017 - In an effort to improve rates of early diagnosis and intervention, researchers at Washington University in St. Louis have developed a blood test that can detect some of the hallmarks of Alzheimer’s disease.

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FDA Approves Puma Biotechnology’s Extended Adjuvant Therapy for Breast

July 19, 2017 - Puma Biotechnology’s breast cancer drug Nerlynx (neratinib) has been approved by the US Food and Drug Administration (FDA).

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Anti-CRISPR Proteins Could Improve Accuracy of Gene Editing

July 14, 2017 - Researchers from the University of California (UC) Berkeley and UC San Francisco have shown that newly-identified anti-CRISPR proteins could help improve the accuracy of the gene editing technique.

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Sorrento Therapeutics Gets FDA Go-Ahead for Cancer Pain Clinical Trial

July 5, 2017 - The FDA has authorized Sorrento Therapeutics’ Investigational New Drug Application (IND) for their chronic pain drug candidate, Resiniferatoxin (RTX).

Featured In: Clinical Trials News, Biotech News

CRISPR Add-on Could Make Gene Editing More Accurate

June 29, 2017 - University of Texas (UT) scientists have developed a technique to predict undesirable editing by the CRISPR tool and help researchers design personalized gene therapies on a patient-by-patient basis.

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FDA Rejects Pfizer's Anemia Drug Biosimilar

June 27, 2017 - Pfizer announced that they have received a Complete Response Letter (CRL) from the FDA regarding its biosimilar version of Amgen’s anemia drug Epogen.

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Sarepta Therapeutics to Partner with Genethon on Gene Therapy for Duchenne

June 22, 2017 - Biopharmaceutical company Sarepta Therapeutics and non-profit rare disease R&D company Genethon have decided to partner to develop novel therapies for Duchenne muscular dystrophy (DMD).

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German Merck Launches Spinoff Immuno-Oncology Company

June 22, 2017 - Merck KGaA has announced the launch of iOnctura SA, a new immuno-oncology company built around two assets from the Healthcare R&D portfolio of the pharmaceutical company.

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UK’s NICE Approves New Crohn’s Disease Therapy

June 20, 2017 - The National Institute for Health and Care Excellence has recommended that Janssen’s Crohn’s disease drug Stelara (ustekinumab) be made available to patients in the UK through the NHS.

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Supreme Court Decision to Support Faster Launch of Biosimilar Drugs

June 13, 2017 - Yesterday, the US Supreme Court overturned an original court’s ruling which prevented Novartis from launching its biosimilar of Amgen’s cancer drug Neupogen, until six months after the pharmaceutical company gained FDA approval.

Featured In: Clinical Trials News

Thousands of Off-Target Mutations Plague CRISPR Gene Editing

May 31, 2017 - A recent study, set to be published in the journal Nature Methods, has highlighted this fact by reporting that the technology may introduce hundreds or thousands of so-called off-target mutations into the genome.

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FDA First: Keytruda Approved for Cancer Treatment Based on Biomarker Alone

May 25, 2017 - For the first time, the FDA has approved a cancer treatment for solid tumors based on the presence of a biomarker, as opposed to specifying a tissue of origin.

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Expanded Indication for Actemra makes it First FDA-Approved Treatment for Giant Cell Arteritis

May 24, 2017 - Genentech’s arthritis drug, Actemra (tocilizumab), was approved by the FDA on Monday to treat adults with giant cell arteritis (GCA).

Featured In: Biotech News

Nanofluidic Device Could Improve Quality of Biologic Drugs

May 24, 2017 - MIT engineers have developed a nanofluidic device capable of assessing the quality of biologic drugs as they’re being manufactured.

Featured In: Biotech News, Drug Safety News

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Shire Releases Positive Late-Stage Clinical Trial Results for HAE Rare Disease Drug

May 19, 2017 - Dublin-based biotechnology company Shire is gearing up to submit a biologics license application (BLA) to the FDA after releasing positive data from its Phase III clinical trial of lanadelumab.

Featured In: Clinical Trials News, Biotech News

Effectiveness of Cancer Immunotherapy Could Be Improved by Blocking Platelet Production

May 8, 2017 - Researchers have identified a new mechanism by which platelets impair T cell activity.

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Some Patients Taking Repatha Will Receive Full Refund if They Experience a Cardiac Event

May 4, 2017 - Cardiovascular disease patients covered under Harvard Pilgrim health plans will now be eligible for a full refund if they experience a cardiac event while taking Amgen’s cholesterol-lowering drug, Repatha.

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Cell Model of Parkinson’s Disease Could Speed Drug Development

May 3, 2017 - To help in the development of new treatments for Parkinson’s disease, researchers at the University of Buffalo have developed stem cells that mimic these oscillations in cell culture.

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Gene Editing Used to Trigger Arthritis Vaccine Production in Living Cells

May 2, 2017 - Researchers at Shriners Hospitals for Children in St. Louis, and the Washington University School of Medicine, have used CRISPR gene editing to engineer stem cells capable of producing an anti-inflammatory arthritis vaccine.

Featured In: Biotech News

Medeor to Start Late-Stage Clinical Trial of Immunotherapy for Transplant Patients

May 1, 2017 - Medeor Therapeutics has just received the FDA go- ahead to start a clinical trial of its cell-based immunotherapy, MDR-101. The personalized therapeutic could replace immune-suppressing drugs in patients who have received an organ transplant.

Featured In: Biotech News, Clinical Trials News

Samsung Bioepis Receives First FDA Drug Approval for Remicade Biosimilar

April 26, 2017 - South Korea-based biopharmaceutical company, Samsung Bioepsis, has received its first product approval for the US market.

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Genentech’s Immunotherapy Gets Accelerated FDA Approval for Advanced Bladder Cancer

April 19, 2017 - The immunotherapy has been granted accelerated approval by the regulator for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC).

Featured In: Biotech News

New CRISPR Gene Editing Enzyme Removed Duchenne Muscular Dystrophy Mutations

April 17, 2017 - For the second time, a team of researchers at UT Southwestern Medical Center have corrected mutations associated with Duchenne muscular dystrophy using CRISPR gene editing.

Featured In: Biotech News

Shire and PatientsLikeMe Collaborate on Rare Disease Study

April 13, 2017 - Biopharmaceutical company, Shire Pharmaceuticals and online patient support community, PatientsLikeMe, have announced that they plan to collaborate with the aim of developing a patient-centered health education platform.

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Gilead’s Hepatitis C Meds Receive FDA Approval for Treatment of Pediatric Patients

April 12, 2017 - The FDA has approved supplemental applications for Gilead’s Harvoni and Sovaldi – both treatments for chronic hepatitis C infection – for pediatric patients age 12 and over.

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Novartis’ CAR-T Immunotherapy Gains FDA Priority Review

April 3, 2017 - Last week, the US Food and Drug Administration (FDA) granted priority review for the company’s investigational T cell therapy, CTL019 (tisagenlecleucel-T), after accepting Novartis’ Biologics License Application (BLA).

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Roche’s Multiple Sclerosis Drug is First Disease-Modifying Therapy Approved by FDA

March 30, 2017 - The US Food and Drug Administration (FDA) has approved Roche’s Ocrevus (ocrelizumab) for the treatment of both relapsing and primary progressive multiple sclerosis (PPMS).

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FDA Approves PD-L1 Immunotherapy Developed by Pfizer and Merck KGaA

March 27, 2017 - Pfizer and Merck KGaA’s PD-L1 inhibitor, Bavencio (avelumab), has become the first immunotherapy to be approved by the US Food and Drug Administration (FDA) to treat a rare form of skin cancer, known as metastatic Merkel cell carcinoma (MCC).

Featured In: Biotech News

New Approach Could Allow Red Blood Cells to be Manufactured

March 27, 2017 - UK researchers at the University of Bristol have developed an immortal line of early adult erythroblasts capable of continuously producing mature red blood cells.

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Lung Cancer Recurrence Could Be Better Detected Using Biomarker Blood Test

March 24, 2017 - The results of a recent prospective clinical trial found that a biomarker blood test could detect lung cancer recurrence a full six months before imaging methods could spot the disease.

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Amgen Identifies Issue with Patient Access to PCSK9 Inhibitor

March 23, 2017 - Most US patients hoping to get their PCSK9 inhibitor medications covered by their prescription drug plan are being denied, according to two new studied conducted by Amgen.

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CRISPR Gene Editing Could Prevent Vision Loss Caused by Retinal Disease

March 16, 2017 - According to a new study published in the journal, Nature Communications, silencing a gene, known as Nrl, using CRISPR could preserve photoreceptors in the eye.

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Mylan, Genentech and Roche Reach Agreement on Biosimilar Cancer Drug

March 15, 2017 - Mylan’s biosimilar version of the breast cancer drug, Herceptin, may soon be available, thanks to a settlement reached between the pharmaceutical company and the makers of the reference biologic, Genentech and Roche.

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Researchers Work Towards Building a Fully-Synthetic Yeast Genome

March 13, 2017 - A global research team working on the Synthetic Yeast Project (Sc2.0), has assembled five new synthetic yeast chromosomes for the commonly-used Baker's yeast (Saccharomyces cerevisiae).

Featured In: Biotech News

European Pharmaceutical Associations Urge Physicians to Exercise Caution When Prescribing Biosimilars

March 10, 2017 - Three pharmaceutical industry groups in the EU have published a document aimed at helping physicians decide when it’s medically appropriate to switch a patient from a biologic to a biosimilar.

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Gene Therapy Could Be Effective Cure for Sickle Cell Disease

March 3, 2017 - A patient in France with sickle cell disease has been successfully treated for the condition using gene therapy.

Featured In: Biotech News

Drug for Dust Mite Allergy Approved by FDA

March 3, 2017 - Good news for house dust mite allergy sufferers: the FDA has approved Merck, Sharp & Dohme Corp.’s Odactra to treat allergic rhinitis and conjunctivitis in patients between the ages of 18 and 65.

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Pfizer and Celltrion Seek Biosimilar Interchangeability for Crohn’s Disease Drug

February 27, 2017 - Pfizer recently reported that its biosimilar version of Johnson and Johnson’s Remicade, showed similar efficacy compared to the reference biologic in patients with moderate-to-severe Crohn’s disease.

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Valeant’s Plaque Psoriasis Drug Gains FDA Approval

February 21, 2017 - The US Food and Drug Administration (FDA) has approved Valeant’s injectable plaque psoriasis drug, Siliq (brodalumab).

Featured In: Biotech News

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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Bristol-Myers Squibb’s Opdivo Immunotherapy Receives FDA Approval for Bladder Cancer

February 7, 2017 - Bristol-Myers Squibb’s immuno-oncology drug, Opdivo, has received US Food and Drug Administration (FDA) approval to treat patients with a common form of bladder cancer, known as urothelial carcinoma.

Featured In: Biotech News

CAR-T Cell Therapy Shows Lasting Results in Two Pediatric Patients

January 27, 2017 - While Cellectis’ immunotherapy agent is now being tested in clinical trials involving both children and adult patients, the two infant girls were the first to receive the treatment back in 2015.

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AbbVie’s Anti-Tau Antibody Enters Phase II Clinical Trials for Alzheimer’s Disease

January 26, 2017 - AbbVie has commenced two Phase II clinical trials for the company’s investigational anti-tau antibody, ABBV- 8E12.

Featured In: Pharmaceutical Marketing News, Biotech News

FDA Draft Guidance on Biosimilar Interchangeability Sets High Standard

January 20, 2017 - The US Food and Drug Administration (FDA) has released some much- anticipated draft guidance on biosimilar interchangeability with its reference product.

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FDA Guidance on Biosimilar Naming to Support Pharmacovigilance

January 16, 2017 - After much speculation and debate, the US Food and Drug Administration (FDA) has released guidance for biologic and biosimilar product naming conventions.

Featured In: Biotech News, Pharmaceutical Marketing News

Merck Files FDA Application for Keytruda/ Chemotherapy Combo for Lung Cancer

January 13, 2017 - This week, Merck submitted a supplemental Biologics License Application to the US Food and Drug Administration (FDA) for a drug combining Keytruda and chemotherapy for the treatment of metastatic or advanced non-squamous non-small cell lung cancer (NSCLC).

Featured In: Biotech News

PVP Biologics Scores Support from Takeda for Celiac Disease Treatment

January 9, 2017 - Takeda Pharmaceuticals and PvP Biologics have entered into a global agreement to co-develop an enzyme – called KumaMax – designed to help treat patients with celiac disease.

Featured In: Biotech News

Guardant Health to Develop 500-Plus-Gene Liquid Biopsy to Support Drug Development

January 9, 2017 - Genomic testing company, Guardant Health, has announced that it will develop a liquid biopsy panel comprised of over 500 genes to support both cancer drug development and clinical trials.

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New Therapy for Rare Spinal Muscular Atrophy Receives FDA Approval

January 5, 2017 - The drug is the first to be approved to treat the rare genetic disease in both adults and children.

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Stable Synthetic Stem Cells Could Reduce Risks and Improve Benefits

January 4, 2017 - Synthetic cardiac stem cells have been developed by researchers at North Carolina (NC) State University, in collaboration with the University of North Carolina (UNC) at Chapel Hill and First Affiliated Hospital of Zhengzhou University.

Featured In: Biotech News

Four CRISPR Companies Reach Agreement in Patent Case

December 20, 2016 - Four companies focusing on CRISPR gene editing have agreed to form an intellectual property (IP) alliance.

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CAR-T Win: Bluebird Bio Announces Positive Phase I Clinical Trial Results

December 2, 2016 - Earlier this week, biotech company bluebird bio released positive interim results from their Phase I clinical trial of CAR-T immunotherapy, in patients with relapsed or refractory multiple myeloma.

Featured In: Biotech News

Canadian Government Invests Millions in Stem Cell Research Projects

November 29, 2016 - This funding will be used to support 31 projects and clinical trials being conducted across Canada.

Featured In: Biotech News, Clinical Trials News

Not Just A Cancer Treatment: Immunotherapy Could Be Effective Against HIV

November 23, 2016 - By injecting a broadly neutralizing HIV antibody (bNAb), known as VRC01, into patients with chronic HIV infections, the researchers found that the time to HIV viral rebound was moderately delayed.

Featured In: Biotech News

First-In-Human Study Using CRISPR Gene Editing

November 17, 2016 - A group of researchers at Sichuan University in Chengdu, China, have become the first to inject CRISPR gene- edited cells into a human patient.

Featured In: Biotech News, Clinical Trials News

Cholesterol-Lowering Biologic Shows Promise in Early-Stage Clinical Trial

November 16, 2016 - Research conducted at the University of Pennsylvania has found that a new injectable biologic drug may be effective at reducing triglyceride levels.

Featured In: Biotech News, Clinical Trials News

Inovio’s DNA-Based Zika Vaccine Shows Promise In Preclinical Study

November 14, 2016 - Inovio Pharmaceuticals Inc. is making swift progress in the development of a vaccine to prevent against Zika virus infection.

Featured In: Biotech News

Some Immuno-Oncology Drugs Carry Risk of Rare Heart Damage

November 7, 2016 - Two weeks after beginning treatment with Bristol-Myers Squibb’s Opdivo and Yervoy immuno-oncology drug combo, two melanoma patients died as a result of myocarditis.

Featured In: Biotech News

9 Out Of 10 US Doctors Willing To Prescribe Biosimilars

November 4, 2016 - Ninety-one percent of US physicians would be willing to prescribe a biosimilar over its branded biologic, given the right circumstances.

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Combination Therapy Could Be Effective Against Ovarian Cancer

November 3, 2016 - According to the study authors, the triple drug combination therapy could be an effective treatment option for patients whose cancer has developed resistance to chemotherapy and other conventional treatments.

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NICE Changes Stance on Kidney Cancer Immunotherapy, Opdivo

October 24, 2016 - UK pharmaceutical cost regulator, the National Institute for Health and Care Excellence (NICE), has reversed its previous decision and announced it supports the use of Opdivo (nivolumab) as a cost-effective treatment option for patients with advanced renal cell carcinoma.

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FDA Approves First Anti-PDL1 Cancer Immunotherapy for Metastatic Lung Cancer

October 20, 2016 - Roche’s biotechnology division, Genentech, has just received US Food and Drug Administration (FDA) approval for their non-small cell lung cancer drug, Tecentriq (atezolizumab).

Featured In: Biotech News

Clinical Trial Results Released For Herpes Vaccine

October 19, 2016 - Biotech company, Rational Vaccines has released promising data from their Phase I human clinical trial testing their Herpes vaccine candidate, Theravax.

Featured In: Biotech News, Clinical Trials News

Image-Guided Cryoablation Could Improve Effectiveness of Cancer Immunotherapy

October 14, 2016 - Dr. Jason Williams, a medical doctor with Image Guided Cancer Specialist, has developed a method of delivering immunotherapy cancer drugs directly into tumors using image-guided cryoablation.

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Amgen’s Humira Biosimilar Gets FDA Green Light

September 27, 2016 - In a major win for Amgen, the US Food and Drug Administration (FDA) has approved Amjevita (adalimumab-atto), a biosimilar of AbbVie’s Humira (adalimumab).

Featured In: Biotech News, Pharmaceutical Marketing News

Ultrasound Delivery Could Improve Efficacy Of Gene Therapy

September 6, 2016 - Researchers at the University of Pittsburgh have used ultrasound and microbubbles to effectively deliver gene therapy into cells.

Featured In: Biotech News, Medical Device News

Gene Therapy Drug May Show Promise In Treatment Of Huntington’s Disease

September 1, 2016 - Researchers at St. Jude’s Children’s Research Hospital have pioneered the use of CRISPR gene editing as a therapeutic for sickle cell disease and other blood disorders.

Featured In: Biotech News

CRISPR Gene Editing Could Be Used To Treat Sickle Cell Disease

August 16, 2016 - A novel gene therapy drug developed by antibody company Vybion has been shown to block cellular gene dysregulation and delay cognitive and motor problems associated with Huntington’s disease.

Featured In: Biotech News

Microbiome Cancer Immunotherapy Project Aims To Improve Oncology Drugs

August 15, 2016 - A new class of microbiome-derived cancer immunotherapy agents to be used in combination with checkpoint inhibitor drugs, are set to be developed by Vedanta Biosciences and NYU Langone Medical Center.

Featured In: Biotech News

First Vaccine For Chlamydia Developed By McMaster Researchers

July 22, 2016 - A vaccine designed to prevent the common sexually- transmitted infection (STI), chlamydia, has been developed by researchers at the Michael G. DeGroote Institute for Infectious Disease Research at McMaster University.

Featured In: Biotech News

Vaccine For Alzheimer’s Disease Closer To Clinical Trials

July 20, 2016 - Researchers in the US and Australia have developed a vaccine formulation which targets two of the key proteins involved in Alzheimer’s disease progression.

Featured In: Biotech News

Kite Pharma’s CAR-T Clinical Trial To Use Chemotherapy Drug Implicated In Patient Deaths

July 15, 2016 - In its upcoming clinical trial of their CAR-T therapy, Kite Pharma plans to use low-dose fludarabine as a preconditioning agent – a drug implicated in the death of three patients in a similar study conducted by Juno Therapeutics.

Featured In: Biotech News, Clinical Trials News

Seres Therapeutics To Conduct First Clinical Trial Of Synthetic Microbiome Drug

July 8, 2016 - Microbiome therapeutics company Seres has announced it has started a Phase Ib clinical trial of its SER-262 oral microbiome therapy.

Featured In: Biotech News, Clinical Trials News

Federal Appeals Court Upholds Biosimilar Marketing Rules

July 7, 2016 - Biosimilar drugmakers are required by law to give brand-name pharmaceutical companies six months’ notice before launching their copy on the market, ruled a federal appeals court.

Featured In: Biotech News, Pharmaceutical Marketing

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.

Featured In: Biotech News, Pharmaceutical News

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.

Featured In: Biotech News, Pharmaceutical News

Internet Billionaire To Fund First CRISPR Clinical Trial

June 23, 2016 - On Tuesday, a National Institutes of Health (NIH) panel gave the go-ahead to the first ever CRISPR clinical trial funded by internet billionaire, Sean Parker.

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Inovio’s Zika Vaccine Enters Early Clinical Trials

June 22, 2016 - Inovio Pharmaceuticals plans to start a Phase I clinical trial of its experimental Zika vaccine in the next few weeks.

Featured In: Biotech News, Clinical Trials News

Takeda Begins Phase IIb Clinical Trial Of Norovirus Vaccine

June 22, 2016 - The only vaccine currently in development to prevent norovirus infection has just entered a Phase IIb clinical trial.

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Novartis To Launch Five New Biosimilar Drugs By 2020

June 21, 2016 - Novartis’ generics division, Sandoz, has announced that it plans to push five new biosimilar drugs through the product pipeline all the way to approval by 2020.

Featured In: Biotech News

First Single-Dose Cholera Vaccine Approved By FDA

June 15, 2016 - The vaccine is designed to protect against cholera infection and is the world’s first single-dose preventative treatment.

Featured In: Biotech News, Life Science News, Pharmaceutical Marketing News

Autologous Stem Cell Transplantation Offers New Treatment Option For HIV-Associated Lymphoma

June 15, 2016 - Patients with HIV-associated lymphoma have long been thought of as poor candidates for the standard treatment for the disease. According to a new study however, these patients have similar survival rates and face comparable risks when treated with an autologous stem cell transplant, compared to HIV-negative individuals with lymphoma.

Using Viral Therapy To Reverse Liver Disease

June 6, 2016 - Researchers have used a modified virus to help repair damaged hepatocytes in mice with liver disease.

Angina Frequency Reduced By Treatment With CD34 Positive Cells

June 2, 2016 - A recent clinical trial has found that patients with class III-IV refractory angina could benefit from a dose of cells positive for a protein involved with vascular-associated tissue changes, known as CD34.

CRISPR Technique Removes HIV Genes From Live Animal Models

May 25, 2016 - For the first time, researchers have used the CRISPR technique to successfully remove HIV genes from the genomes of animals infected with the retrovirus.

Universal Donor Cancer Immunotherapy To Be Developed By Regen Biopharma

May 24, 2016 - Early-stage biotech company, Regen BioPharma, has started preclinical development on the first cancer immunotherapy using cells extracted from cord blood.

New Antimicrobial Peptide Effective Against Respiratory Virus and Biofilms

May 12, 2016 - A novel compound capable of simultaneously breaking down tough bacterial biofilms and killing a deadly respiratory virus, has been developed by researchers at the University of Pittsburgh Center for Vaccine Research (CVR).

CAR-T Cell Immunotherapy Leads To 90 Percent Remission Rate In Leukemia Clinical Trial

May 9, 2016 - The trial – which took ten months to complete – resulted in a complete remission rate of 90 percent, and a minimal residual disease (MRD- negative) rate of 80 percent.

Gene Therapy Clinical Trial For Rare Neurodegenerative Disorder Commences

April 29, 2016 - Nationwide Children’s Hospital has just started a first- in-human clinical trial testing the effectiveness of gene therapy at treating the rare neurodegenerative disorder, Batten disease CLN6.

CAR-T Cell Immunotherapy Could Be Viable Treatment For Some Brain Cancers

April 25, 2016 - A Phase I clinical trial testing whether CAR-T cell immunotherapy could be a viable treatment for a type of brain cancer known as glioblastoma, has found that the therapy was both safe and effective.

CRISPR Gene Editing Technique Gets Precision Upgrade

April 22, 2016 - Harvard researchers have improved the CRISPR gene editing tool, to allow the technique to be used to change single bases in the DNA of a specific gene.

CRISPR Collaboration Announced Between Regeneron and Intellia Therapeutics

April 14, 2016 - Biotech company Regeneron Pharmaceuticals and gene editing company Intellia Therapeutics, have announced a licensing and collaboration agreement using the CRISPR/Cas9 technique to develop new therapies for a range of diseases.

Bioengineered Skin Displays Characteristics Of Integumentary Organ System

April 5, 2016 - Japanese scientists have performed a skin transplant on mice using 3-D bioengineered tissue generated from pluripotent stem cells.

Microsoft Co-Founder Invests $100 Million In Bioscience Research

March 28, 2016 - Paul Allen – a billionaire philanthropist and co-founder of Microsoft – has founded a $100 million bioscience research initiative to fund innovative research over the next 10 years.

New Stem Cell Technology To Improve Glaucoma Treatment

March 24, 2016 - Working towards more effective treatments for glaucoma, researchers from Indiana University-Purdue University Indianapolis (IUPUI) have developed a new method of generating retinal ganglion cells from human skin cell-derived stem cells.

Cellectis Partners With MabQuest To Develop New Cancer Immunotherapy Antibodies

March 21, 2016 - French biopharmaceutical company Cellectis and Netherlands-based biotech MabQuest, have announced they will be collaborating to develop a novel class of monoclonal antibodies that are antagonistic to a protein called PD-1.

Bispecifics Could Rival CAR-T Immunotherapy

March 15, 2016 - While the CAR-T approach has produced some promising results so far, Roche is intent on developing a similarly- effective therapy, without requiring physicians to harvest immune cells from patients.

Charity Opposes Pfizer’s Indian Patent On Pneumonia Vaccine

March 15, 2016 - Doctors Without Borders are in the news again. This time, the humanitarian group are attempting to prevent pharma giant Pfizer from filing a patent on their pneumonia vaccine in India.

Mitsubishi’s Tobacco-Based Influenza Vaccine Could Rival Egg-Based Preparations

March 14, 2016 - According to research and consulting firm, GlobalData, the new tobacco-based influenza vaccine – under development by Mitsubishi Tanabe Pharma – could be substantial competition for more traditional egg-based preparations.

New Vaccine For Tropical Bacterial Infection, Melioidosis

March 2, 2016 - Researchers at the University of Exeter have developed a potentially life-saving vaccine for melioidosis – a bacterial infection also known as Whitmore’s disease.

Genetic Blood Test Identifies Inherited Heart Conditions

February 23, 2016 - Researchers at sites in Singapore and the UK have developed a new blood test – called the TruSight Cardio Sequencing Kit – capable of diagnosing a range of genetic heart conditions.

Canadian Biotech Startup Tackles Blood Cancer and Rare Disease

February 23, 2016 - A new Toronto-based biotech company has announced two novel ex vivo treatments for blood cancer and a rare disease, using gene therapy.

CAR-T Technology Could Be Effective Treatment For Blood Cancers

February 18, 2016 - The Annual Meeting of the American Association for the Advancement of Science (AAAS 2016) took place last weekend, and some exciting new progress has been made in the field of CAR-T therapies for blood cancer.

Indian Biotech Has Two Zika Vaccine Candidates In Development

February 10, 2016 - According to an announcement made by India-based Bharat Biotech last week, the company has been working on two candidates for the Zika vaccine for more than a year.

Atomo Diagnostics Receives $6 Million To Launch Its HIV Test In Emerging Markets

February 3, 2016 - According to a press release issued by Australia-based test developer, Atomo Diagnostics, the company has received $6 million in loan money from the Global Health Investment Fund (GHIF) in support of their self-diagnostic for HIV infection.

UK Cost Agency Backs Seven Biologics For Rheumatoid Arthritis

January 28, 2016 - The National Institute for Heath and Care Excellence (NICE) – a UK cost-effectiveness agency – is backing seven biological disease modifying drugs designed to treat severe rheumatoid arthritis.

Two GlaxoSmithKline Scientists And Three Others Arrested After Attempting To Steal Biopharma Trade Secrets

January 22, 2016 - According to a statement released by the US Attorney’s Office of the Eastern District of Pennsylvania, five individuals – including two GlaxoSmithKline employees – have been charged with attempting to steal trade secrets from the biopharma giant.

Sanofi Pasteur Provides Funding To The Human Vaccines Project

January 21, 2016 - Sanofi’s vaccines unit, Sanofi Pasteur, has agreed to partially fund the Human Vaccines Project – a non- profit, global consortium of researchers and private partners working towards a better understanding of the human immune system.

Immunotherapy Potentially Effective Against Two Deadly Ebola Strains

January 14, 2016 - Antibodies developed by researchers at Albert Einstein College of Medicine, in collaboration with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), may be effective against the two most lethal strains of the Ebola virus.

Illumina To Develop Blood Test For Early Detection Of Cancer

January 13, 2016 - San Diego-based sequencing company Illumina has announced they will be developing blood tests for early-detection of a wide range of cancers, before patients develop any symptoms.

Shire Finalizes Deal To Acquire Baxalta For $32 Billion

January 12, 2016 - After six months of negotiations, Shire has finally announced they’ve reached an agreement to acquire Baxalta for $32 billion.

Roche Looks To Assess Arthritis Drug As Possible Treatment For PAH

January 8, 2016 - Swiss drugmaker Roche has formed an alliance with the UK’s Department of Health to conduct a series of clinical trials aimed at determining whether the company’s arthritis biologic, tocilizumab (or Actemra), is effective at treating pulmonary arterial hypertension (PAH).

Bayer and CRISPR Therapeutics Collaborate To Develop Cures For Genetic Diseases

January 5, 2016 - Late last month, Bayer and CRISPR Therapeutics announced their intention to form a joint venture combining the CRISPR-Cas9 gene editing tool created by its namesake company with Bayer’s knowledge of disease treatment.

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