Pfizer and Bain Capital have teamed up to form a new biotech, Cerevel Theracpeutics. The company will focus on development drug candidates to treat disorders of the central nervous system. Prizer is contributing a portfolio of pre-commercial neuroscience assets and Bain Capital is providing #350 million in capital.
Teva has lost its appeal to maintain several patents on its 40 mg version of its multiple sclerosis drug Copaxone.
The drug is a key sales contributor for Teva. Sales of the short-acting version of the drug have plummeted with Mylan and Novartis generics out there. Sales for the 20mg and 40mg versions together amounted to $940 million in North America…
Insmed’s Arikayce has become the first drug approved under a novel FDA pathway designed to speed development of antibiotics.
The active component of antibiotic Arikayce is amikacin, a decade-old antibiotic that’s on the WHO’s essential drug list. But instead of administering it intravenously, Insmed created an…
Big Pharma is expected to get much bigger over the next several years, with the companies competing to grow their sales in a list of established and emerging therapeutic areas, notably cancer and immunology.
Regeneron is planning a build out of its second campus in Rensselaer, New York. The plan includes adding manufacturing capacity, laboratory space and warehouse facilities. With the expansion, Regeneron will be 1,500 jobs over the next seven years and receiving $140 million in tax incentives from the state.
AstraZeneca’s severe asthma drug, tezepelumab, has received breakthrough therapy designation from the FDA. Tezepelumab treats a broader respiratory population than AZ’s FasenraIt which could help boost the company in its battle with GlaxoSmithKline.
Otsuka’s Abilify MyCite, the only FDA-approved digital pill, has taken another step toward patients thanks to a deal with Magellan Health to distribute the medicine through its network of mental health providers.
The chemo-free combination of Imbruvica (a drug split by AbbVie and Johnson & Johnson) and Roche’s Rituxan has received FDA approval for the treatment of the rare blood cancer Waldenström's macroglobulinemia.
A commercial for Boston Scientific’s Watchman heart implant device, with small daytime placements in Detroit, Phoenix, San Diego and Tampa has been expanded into select additional markets. While the commercial has not gone national yet, it is treading on the anticoagulants market.
In a new TV campaign, Sanofi targets parents stressing that, for effective meningitis prevention, it takes two vaccinations. Encouraging parents to make sure that their high school age children get a second MCV4 dose needed to complete the quadrivalent meningococcal conjugate vaccine.
Shire has discontinued the Phase 2 clinical trial of SHP626 (volixibat), an FDA fast-tracked fatty liver disease drug which was originally licensed by Lumena Pharmaceuticals.
The FDA has approved AbbVie’s Orilissa, a treatment for pain associated with endometriosis. This is the first oral drug to receive approval in over a decade. It's expected to roll out in early August with an $845 per month price tag.
Moderna Therapeutics, a Cambridge, Massachusetts-based biotech, has opened a $110 million, 200,000-square-foot manufacturing plant in nearby Norwood, Massachusetts. One hundred fifty workers have already been hired and it is expected that they will hire another 50 this year.
Zhejiang Huahai Pharmaceutical, a Chinese active ingredient manufacturer, voluntarily notified the European Medicines Agency (EMA) that it had identified N-nitrosodimethylamine (NDMA), a chemical that might lead to cancer, in its valsartan provided to the European market. Medicines containing valsartan made by Huahai are being recalled across Europe, while the EMA carries out a thorough review to determine the impact.
Deborah Dunsire, former CEO of Millennium, whose background is primarily in oncology, has been named CEO of Lundbeck, a neuroscience specialist. Lundbeck has been searching for a new CEO since November of last year when Kåre Schultz left for Teva.
After twenty years, Array BioPharma has received its first two drug approvals from the FDA. The approval is for the cancer drug combo of Mektowv, a MEK inhibitor, and Braftovi, a BRAF inhibitor, will be used to treat patients with melanoma that cannot be surgically removed or has spread throughout the body.
China’s Drug Administration has approved Opdivo, the country’s first immuno-oncology and the first PD-1—therapy. The drug’s developer, Bristol-Myers Squibb, won’t be celebrating long as there are other therapies to come including Merck’s Ketruda.
During an inspection AbbVie’s manufacturing plant located in North Chicago, FDA inspectors found that AbbVie had received five complaints tied to deaths after taking Humira and Venclexta. While the drugmaker reported those, the FDA says they did not go back and compile historical data about death complaints tied to drugs coming from the same lots. It turns out those lots had been tied to another 8 to 11 complaints each, the FDA noted in a Form 483 seen by STAT.
As this year’s American Society of Clinical Oncology meeting winds down, this article touches base on featured data and insights from industry leaders such as Merck, AstraZeneca Takeda and many more.
Loxo Oncology’s has just been awarded a priority review for larotrectinib, a Bayer-partnered drug to be used a treatment for solid tumors carrying a specific mutation—regardless of where they appear in the body.
The results of the FDA review should be announced in November.