A smartphone app designed by Pear Therapeutics has received FDA clearance for treating patients suffering from opioid abuse. This is the first prescription digital therapeutic to treat opioid addiction to be cleared by the FDA.
The app will be used in conjunction with standard outpatient…
Bayer announced last week that it will close its hemophilia manufacturing facility in Wuppertal, Germany, and lay off 350 workers. Its recombinant factor VIII production will take place at its site in Berkeley, California. The cuts in Germany come on top of the announced layoffs in October of more than 225 manufacturing workers in Berkeley.
The FDA has extended the patent for Pfizer’s top selling drug, Lyrica, which was set to expire at the end of this year. The company now has exclusivity until June 30, 2019. With Lyrica sales reaching nearly $3.5 billion in the US in 2017, this extension will allow Pfizer to protect about half of that figure next year.
Pfizer has announced that as of January 2019 it will be raising prices on 41 of its drugs. Thirty-seven will increase by 5%, three by 3% and one by 9%. In total, these drugs represent about 10% of Pfizer’s portfolio. These increases follow similar increases this past summer to about the same number of drugs.
The third quarter US sales for Regeneron’s Eylea were listed as $1.02 billion. This is the first time the drug has generated over $1 billion in quarterly US sales. Q2 sales were $992 million. In August, Eylea received an FDA nod in wet age-related macular degeneration as a 12-week dosing formulation, and the agency is scheduled to decide on the drug’s use in diabetic retinopathy by May 13, 2019.
Glenmark was one of a number of drugmakers that have decided to build US manufacturing plants due to FDA restrictions on facilities in India that was keeping them from exporting to the US. Glenbrook, a Mumbai-based generics company plans to open its $100 million plant today in North Carolina.
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…
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.
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.
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.
After denying Portola’s Andexxa 19 months ago, the FDA as approved the company’s drug that It is the first and only antidote for life-threatening or uncontrolled bleeding in patients taking blood thinners made with rivaroxaban and apixaban.