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.
After FDA rejections in May 2016 and March 2017 and 2 months after gaining the European go-ahead, AstraZeneca’s Lokelma, used to treat hyperkalemia, has received FDA approval.
The two delays, due to manufacturing issues at a Texas plant, allowed Vifor Pharma’s Veltassa to gain speed as the only drug available to treat hyperkalemia…
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.
Portola will launch Andexxa next month, although…
Nearly a year after stepping down as CEO at Flex Pharma, Christoph Westphal has launched another Boston area company named T-Scan Therapeutics.
T-Scan’s goal will be to develop immunotherapy treatments for cancer.
Westphal has also been a part of a number of other biotechs including Momenta, Alnylam, Acceleron and Sirtris.
Amazon has put one of its plan to sell pharmaceutical drugs on hold. For months they have been trying to get hospitals to come on board with their plan but due to Amazon’s lack of a proper cold-chain logistics plan, they are hesitant.
Shire has agreed sell its oncology business to Servier, based in France, for $2.4 billion deal. Servier will gain an immediate presence in the US with products such as Oncaspar, which Shire acquired from Baxalta. Shire will now focus on rare disease.
After a December announcement that Roche's Tecentrig, Avastin and chemo together had cut patients' risk of cancer worsening and death, they have just released more survival data.
Roche has revealed that in a phase 3 trial, the two meds, combined with chemo, had beaten out an Avastin-chemo combo at prolonging lung cancer patients' lives.
The trial, focused on previously untreated non-small-cell lung cancer patients, showed that the survival benefit extended across various subgroups, and it was seen in patients with tumors expressing varying levels of PD-L1.
Bayer, for a second time in less that a year, has issued a recall on certain Alka-Seltzer Plus packages that were sold in Kroger, Walgreens, CVS and Walmart stores after February 9th. The company stated that these packages may contain the wrong ingrediants and cause "serious health consequences".
When filling out your basketball brackets, have a little pharma fun with this FierceMadness 2018 Drug Name Tournament.