Pharmaceutical & Biotech
News and Insights
Biogen shares jump about 4%
In December, Biogen's drug, Spinraza, was approved to treat a rare infant disease. In the first quarter of 2017, the drug has generated more revenue than expected, raising the company's stock about 4%. Sprinraza is the first drug approved to treat spinal muscular atrophy, a leading genetic cause of death in infants. Click here to view the entire article. ...
FDA approves 12 new drugs in Q1
In recent years the FDA has averaged between 6 and 10 new drugs in the first quarter of the year. This year they have endorsed 13 and approved 12 new drugs including Ocrevus from Roche and Dupixent from partners Sanofi and Regeneron. Click here to view the entire article. ...
Teva receives FDA approval
Teva has just received FDA approval for Austedo, a medication to treat chorea, the involuntary, random and sudden movements that occur in about 90% of patients with Huntington's disease. The orphan drug is just the second green-lighted for chorea treatment and the first-ever deuterated product to win the FDA's favor. Teva plans on pricing the drug at less than half of its competitor Xenazine. Click here to view the entire article. ...
Adverse event reports on the rise
Since 2004 the adverse events reports filed with the FDA have risen five-fold with 1.2 million reports filed in 2015. This news comes on the heels of the new administration promising to speed up the time it takes drugs to get to the market. Even though rates are increasing the FDA has pointed out that not all events reported are directly related to the cause of the drug and the FDA says the data should not be used to estimate a drug's risk. Click here to view the entire article. ...
Amgen's patent fight may push Praluent off the market
Due to an ongoing patent fight, Sanofi and Regeneron's cholesterol drug, Praluent, is gradually losing its market share to Amgen's Repatha. For the week of January 20, Repatha's prescription total hit 3,231, ahead of Praluent's 2,859, Bernstein analyst Ronny Gal reported in a Monday note. The 53%-to-47% ratio is the largest weekly gap since themiddle of last year, the analyst wrote. The fight over the patent comes from the claim that Sanofi and Regeneron knowingly stepped on Amgen's patents when developing Praluent. Click here to view the entire article. ...
Eli Lilly to cut 485 jobs
Due to disappointing EXPEDITION3 trial results, where Alzheimer patients with mild to moderate levels of the disease showed no significant improvements compared to the placebo group, Eli Lilly has decided to lay off 485 employees. Most of the layoffs are in the Alzheimer's unit with the remaining in the animal health division. Click here to read this entire article. ...
Another executive change for GlaxoSmithKline
The latest in a series of newly named Executives at GSK is Deborah Waterhouse. Deborah will replace Dominque Limet, who will step down as its Head of HIV unit ViiV Healthcare in March 2017. GSK's longtime CEO, Andrew Witty will also step down in March. He will be replaced by Emma Walmsley. She will be Big Pharma's first women CEO. Click here to read about other executive changes at GSK. ...
Pharmaceutical sales reps in Chicago will now need a license
In an effort to combat opioid abuse, Chicago's City Council has approved and ordinance that will require all pharmaceutical sales reps to obtain a license to promote their company's drugs. The cost of the license is $750 which will need to be renewed annually. Additionally, those sales reps will need to complete five hours of training every year, including brush-ups on ethics, rules, and safety. The sales representatives will need to keep a detailed log of the doctors and healthcare professionals they visited, what drugs were discussed and samples that were given out. The city hopes to identify trends and prevent misleading promotions. Click here to view the entire article. ...
Soaring US Drug Costs in 2015
New Medicare and Medicaid spending numbers have shown significant price hikes with US drug costs that reached $457 billion in 2015. Medicare reported that 11 drugs have more than doubled in price compared with 2014, and Medicaid saw 20 covered drugs more than double in per-unit cost. Some increases shared are Valeant's anxiety medication Ativan grew 1,264% over the previous year, according to a Centers for Medicare & Medicaid Services (CMS) dashboard that analyzes drug spending. Turing's Daraprim followed with an 874% average per-unit price hike. Click here to view the entire article. ...
Walter Reed Army Institute of Research to begin Zika vaccine testing on humans
The Walter Reed Army Institute of Research has joined Inovio Pharmaceuticals and the NIH as it has moved into human testing for its Zika vaccine. Inovio started testing in June and the NIH followed in August. Walter Reed plans to enroll 75 adults in the Phase I study. Some of the participants will be vaccinated against other flaviviruses such as yellow fever and dengue because immunity to these viruses can cause an outsized immune response to Zika. This is important because many of the US military are vaccinated against flaviviruses before deployment to infected regions. Takeda, Modern and GlaxoSmithKline are also among those in the Zika vaccine R&D race. Click here to view the entire article. ...
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