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.
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".
According to data from real-time TV ad tracker iSpot.tv, fifteen prescription drug brand ads ran 221 times on national TV during the February run of the PyeongChang games on NBC. This represented 4.1% Spend Share of the Voice for all ads running during the Olympics.
The top three ads came from Merck and Pfizer. Merck spent $11.3 million on cancer drug Keytruda. Meanwhile, Pfizer at the Olympics spent $10.9 million on commercials for its metastatic breast cancer treatment Ibrance and another $8.3 million on a Xeljanz XR spot for its rheumatoid arthritis indication.
When looking back on the last two decades of drug launches, Hepatitis C medications have been the most successful. Multiple sclerosis, cancer and eye disease have as well with launches in the last few years.
All-in-all there are five Hep C medications in the top 10, with the top three coming from Gilead Sciences.
California based biotech company, Aimmune, has presented strong phase 3 trial data for its peanut allergy treatment, AR101.
The 12-month study, which enrolled nearly 500 children who are intolerant to peanut protein showed promising results. Each child was randomized to receive AR101 or placebo. After a 22-week dose escalation phase, participants continued to take 300mg a day of peanut flour AR101 or placebo until the end of the study.
Takeda has been awarded fast track status for their vaccine for treatment of the Zika virus. Currently, there are no approved vaccines or drugs against the infection, which can cause microcephaly and other congenital brain abnormalities in infants born to infected mothers. For Takeda, the designation means more frequent interactions with the agency and eligibility for accelerated approval and a priority review.
The FDA has approved AstraZeneca's Lynparza, for treatment of BRCA-mutated breast cancer. This is the first drug to treat this type of cancer and the first for the new field of oncology medications known as PARP inhibitors.
This is also a boast for Merck which signed an $8.5 billion deal with AstraZeneca in July to share Lynparza and study the medication in combination with its own immunotherapy, Keytruda, as well as AstraZeneca's fellow PD-1, Imfinzi.
Repatha, Amgen's cholesterol drug, has been approved by the FDA to be used as a cardiovascular prevention medication. Data from a its Fourier trial showed that Repatha reduced heart attack risks by 27%, stroke by 21% and coronary revascularizations by 22%. With this approval, Repatha becomes the first in its class of pricey new cholesterol drugs to boast the indication.
GlaxoSmithKline is hoping to improve COPD patient selection with an Owlstone Medical's Breath Biopsy platform, which will analyze biomarkers from breath to produce data that can improve outcomes and cut costs, into its phase 2 trial of COPD candidate danirixin.
This platform will be used to evaluate the effects of danirixin on COPD and see if it can help with identifying the right patient for the right treatment.
Merck sponsored an Alexa Diabetes Challenge with at $125,000 prize for the first place finisher. They had 96 submissions from researchers, software companies, startups and healthcare providers, which were tapered down to five finalists. These finalists then presented their ideas live to an audience and panel of judges in late September.
The winner was Wellpepper who designed Sugarpod, a voice-enabled diabetes care plan. This allows users to use their voices to complete daily tasks, from recording blood sugar levels and mealtimes to tracking their medication adherence.
The FDA just approved Roche's Alexensa for treatment of newly diagnosed patients with ALK-positive disease. Pfizer's Xalkori was the first drug approved to target tumors that test positive for an ALK gene abnormality and is the current market leader.
In the phase 3 trial that supported Alecensa's new approval, the drug topped Xalkori at holding off cancer growth by a wide margin. Median progression-free survival was 25.7 months for Alecensa patients, compared with 10.4 months for those taking Xalkori.
After a recent shortage of Shire's rare disease drug, Cinryze, they are looking to bring some manufacturing in house. This comes on the heels of Shire announcing the closer of three more plants.
Shire has already asked the FDA for permission to manufacture Cinryze at one of the plants it received in its Baxalta buyout last year and is hopeful that production can begin in the first quarter of 2018.
The good news keeps rolling in for Merck's Keytruda. After receiving 3 FDA approvals in May, Merck has just received the go ahead for the treatment of two types of recurrent or advanced gastric cancer. Patients must have already received at least two prior rounds of therapy.
Gilead Sciences has announced an $11.9 billion buyout of Kite Pharma which includes the biotech's promising CAR-T treatment Axi-Cel.
In the last year, Kite and Axi-Cell have moved into a leadership position with only Novartis ahead on the push to market.
As CAR-T technology nears the market, the cost of the treatment has yet to be determined. Novartis will likely have to set numbers first as its CAR-T medication CTL019, which received FDA backing in June, is positioned to reach the market ahead of Kite.
Enjoy a look back at 10 years of rumors and deals in biopharma and how they changed the industry landscape. Whether big or small, bidding contests or smooth transactions, some have worked well while others not so much.