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Take a look at what’s going on with pharma and biotech in regulatory intelligence this week:
Boston Scientific has won pre-market approval for its Resonate line of defibrillators. The company claims the defibrillators feature a technology that delivers twice the usable battery capacity of competing devices. (MassDevice)
FDA approved the first ALS drug in more than 2 decades. The FDA has approved Mitsubishi Tanabe Pharma Corp’s edaravone for the treatment of amyotrophic lateral sclerosis (ALS) aka Lou Gehrig’s disease. (Reuters)
The FDA has granted Fast Track designation for Oncolytics Biotech’s immuno-oncology drug, Reolysin, for the treatment of metastatic breast cancer. (PRNewswire)
Teva’s drug failed in Phase 3 multiple sclerosis (MS) trial. Teva and Active Biotech’s laquinimod missed the primary endpoint in a Phase 3 study for the treatment of relapsing-remitting multiple sclerosis. (FierceBiotech)
Roche’s Tecentriq failed a Phase 3 trial in second-line bladder cancer, raising concerns that the FDA may revoke the conditional approval for that indication. (FiercePharma)
Scientists at NASA’s Jet Propulsion Laboratory (JPL) have sent spacecraft deep into the cosmos. Now, they’re exploring another mysterious terrain: the breast.
From studying space and the terrain of planets to analyzing extremely small microorganisms on the breast, read the story behind the innovation of how NASA’s space technology became utilized for researching breast cancer.
After this first medical initiative, a new department at JPL was created for scientists and engineers to come together and work on medical projects. See more ways this type of collaborative research can be applied to address medical questions.
Explore some interesting things going on with pharma and biotech in regulatory intelligence this week!
FDA grants accelerated approval for AstraZeneca’s immunotherapy, Durvalumab, for the treatment of advanced bladder cancer. It is the first approved indication for a product the company hopes will become a blockbuster. (Reuters)
Altor BioScience announced that it has received Fast Track designation from the FDA for ALT-803, its investigational bladder cancer drug. ALT-803, an interleukin-15 (IL-15) agonist complex, is being evaluated for the treatment of non-muscle invasive bladder cancer. Altor will present results from its Phase 1b study at the American Urological Association Annual Meeting on May 12. (Business Wire)
Novo Nordisk reached a settlement in a whistleblower lawsuit alleging that the company ran a “white-coat marketing scheme”. The suit claims that the company partnered with a clinical education company to hire and train certified diabetes educators & provide free services to gain access to physician practices. (FiercePharma)
Takeda has received accelerated approval for Alunbrig, a second-line treatment for patients with a specific type of lung cancer. Takeda acquired Ariad, the drug’s developer, in mid-February. (Reuters)
Home blood pressure monitors are under scrutiny. A recent study indicates that home blood pressure monitors may be too inaccurate to be useful in managing the disease of patients with hypertension, the “number one cause of death and disability in the world”. (Reuters)
Have a look at what’s going on with pharma and biotech in regulatory intelligence this week:
FDA approved Genentech’s Lucentis (ranibizumab) for all forms of diabetic retinopathy. (Reuters)
Roche announced that the FDA granted accelerated approval for Tecentriq for the treatment of bladder cancer in patients who are not eligible for cisplatin chemotherapy. Tecentriq, an anti-PD-L1 immunotherapy was previously approved for the treatment of bladder cancer in patients who have progressed during or after any platinum-containing chemotherapy or within 12 months of receiving chemotherapy before or after surgery. (FirstWordPharma)
OncoMed Pharmaceuticals said that its drug, Tarextumab, which was being evaluated in combination with chemotherapy for the treatment of patients with small-cell lung cancer (SCLC), failed to meet the primary endpoint of a Phase 2 study. (FirstWordPharma)
Bristol-Meyers Squibb (BMS) and Nordic Bioscience announced that they will partner on the development of biomarker technology. Under the agreement, the companies will collaborate on the development of translational biomarkers and diagnostics for the monitoring of nonalcoholic steatohepatitis (NASH) and other fibrotic diseases. (GEN)
FDA advisory committee to review Puma’s Neratinib for the extended adjuvant treatment of HER2-positive breast cancer. Puma Biotechnology announced that the FDA has scheduled an Oncologic Drugs Advisory Committee (ODAC) discussion for Neratinib on May 24, 2017. (BusinessWire)
Peruse what’s going on in regulatory intelligence with pharma and biotech this week:
FDA warns Mylan. Mylan, the embroiled maker of the EpiPen, received a warning letter from FDA citing quality concerns about its India-based drug manufacturing facility. (BusinessInsider)
The National Institute for Health and Care Excellence (NICE) declined Bristol-Myers Squibb’s immunotherapy drug, Opdivo, which treats head and neck cancer. (Reuters)
Rare Disease Drug Development Trends: Five Things to Know. BioPharmaDive provides an overview of five trends shaping the rare disease market. (BioPharmaDIVE)
ArQule announced that the FDA has approved the company’s investigational new drug application for ARQ 531. ArQule will begin Phase 1 clinical trials to evaluate ARQ 531 in patients with B-cell malignancies. (BusinessWire)
Cytori to begin cell therapy trial. The FDA has approved an investigational device exemption (IDE) for a pilot trial of Cytori’s cell therapy in patients with thermal burn injury. (MassDevice)
Here’s a look at what’s going on with pharma and biotech in regulatory intelligence this week:
Cancer immunotherapy comes at a hefty price. Some cancer drugs that improve overall survival cost more than $250,000 per year. Learn more about the exploding market of cancer immunotherapy. (Reuters)
Expanded testing for Zika vaccine. More than 2,000 volunteers are enrolled in a round of clinical trials for a potential vaccine for the Zika virus. The vaccine, which was developed by scientists at the National Institute of Allergy and Infectious Diseases, could be available by the end of this year. (Washington Post)
Biogen wins Tecfidera patent dispute. The US Patent Trial and Appeal Board ruled against Forward Pharma A/S, finding Biogen’s patents on Tecfidera to be valid. Tecfidera, which treats multiple sclerosis (MS), had sales of about $4B in 2016. The ruling frees Biogen from future royalty payments to the Danish company. (Reuters)
Pfizer has received approval of a supplemental New Drug Application (sNDA) for Ibrance, converting the accelerated approval of the product to regular approval. Ibrance treats hormone receptor-positive, HER2-negative metastatic breast cancer and can now be administered with an aromatase inhibitor, in addition to the original indication, in combination with letrozole. (Pfizer)
Wearable medical device may extend the lives of patients with brain cancer. Data presented this week suggests that a wearable medical device that delivers electrical fields through the scalp may extend the survival of patients with brain tumors. The study, conducted in the U.S. and abroad, indicates that electrical fields may block the division of cancer cells in patients who are also receiving chemotherapy. (Washington Post)