fda

Platinum Biologics. It is a privately held company that develops and manufactures biologics, including monoclonal antibodies, vaccines, and gene therapies. The company is headquartered in San Diego, California, and has offices in Europe and Asia. Platinum Biologics is a legal company. It is...

In my opinion, the below is some good information. I do worry because the whole same staff including the doctor moved under the name of another Flordia company and they are still selling these questionable products. They all seem very similar. Regenerative Labs received a warning letter from...

Clinical-stage biotech company Pfenex gets FDA's approval for PF708. Pfenex is conducting a comparative study between PF708 and Eli Lilly's Forteo and will submit the final study report to FDA later this month.

Last week, Gilead failed in Phase 3 clinical trial for NASH drug. Today, Intercept has become the first player in the NASH area to complete a pivotal Phase 3 study in patients with liver fibrosis.

Axsome Therapeutics stock skyrockets on positive outcome from Alzheimer's disease trial https://news.alphastreet.com/axsome-therapeutics-nasdaq-axsm-stock-almost-doubles-on-positive-outcome-from-alzheimers-disease-trial-in-premarket/

United Therapeutics signs an agreement with Arena in a deal worth $1.2 billion. It will pay $800 million as upfront payment to Arena and $400 million as potential milestone payments. This is what exactly Arena investors have been looking for. This will be a win-win deal for both the companies...

I expect that Amarin will bounce back from the recent sell-off. Most of the doctors who participated in the AHA event has said that they will prescribe Vascepa and next year the biggies like Pfizer might considering acquiring Amarin...

After announcing positive results for the treatment of cystic fibrosis, Proteostasis Therapeutics stock skyrocketed more than 400% and reached the double-digit mark after 18 months. https://news.alphastreet.com/proteostasis-therapeutics-stock-skyrockets-on-positive-cystic-fibrosis-trial-results/

Teva pharma receives a booster shot with FDA's approval for its generic version of EpiPen and EpiPen Jr. This will end the monopoly of Mylan. Also, Teva and Regeneron announce positive Phase 3 Fasinumab results in patients with chronic pain from osteoarthritis...

Shares of biotech company Biogen (BIIB) rallied on Thursday during the after-hours trading after the company said it achieved positive results from final analysis of its Phase II trial of an Alzheimer’s drug. The advanced drug candidate, BAN2401, was developed in partnership with a Tokyo-based...

Pfizer blockbuster drug Xeljanz has won itself a new regulatory approval to treat adults with inflammatory bowel disease (IBD). This recent approval will help propel the company’s sales significantly. Pfizer’s Xeljanz is the first and only JAK inhibitor that obtained the FDA’s blessing to treat...

Just days after FDA announced a list of companies that use “gaming” tactics to delay the entry of the generic competitors, Celgene plunges to a new 52-week low. Celgene topped FDA’s list with 31 complaints. https://news.alphastreet.com/celgene-plunges-to-a-new-52-week-low-battered-by-setbacks/

FDA approves Lucemyra, first drug to curb opioid withdrawal symptoms. Considering the severity of opioid addiction, the FDA had expedited the approval process. Kentucky-based US WorldMeds, the manufacture of Lucemyra, is required to conduct further clinical trials in young people and...

https://news.alphastreet.com/dermira-suffers-a-fatal-fall-after-catastrophic-trial-fail/ Shares of the skin specialist tanked almost 60% on Monday after the company announced that its closely-watched experimental acne drug failed to meet the objectives of two phase 3 clinical trials.

https://news.alphastreet.com/celgenes-potential-blockbuster-drug-filing-fails-to-pass-the-muster-with-the-fda/ “Refuse to file” letter sent to Celgene by FDA for the NDA filed for Ozanimod drug for treating patients with relapsed multiple sclerosis

2/25/18 The US Food and Drug Administration has issued a Form 483 and the drugmaker is preparing its response to the observations, Sun Pharma said in a statement on Friday without providing details. The response will be submitted within 15 days and the company “continues to enhance its good...

Celgene strengthens its cancer portfolio by acquiring Impact Biomedicines. After stopping the Crohn's disease treatment trials and cutting down the 2020 outlook recently, this deal is a positive news for Celgene. But Sanofi had sold the rights of fedrantinib to Impact in 2016 when the drug was...

Yesterday a new podcast was released that spends over an hour shedding light on Purdue and the FDA relationship including the original PI from Oxy. Very interesting listen that will surely cause another round of Purdue bashing in the news. The podcast is called "The Uncertain Hour" season 2...

http://alph.st/bf3c0558 Lilly joins the migraine drug race with Novartis and Amgen, as FDA accepts to review Lilly's Galcanezumab. Already, Teva filed a lawsuit in October 2017, seeking to block Lilly's migraine drug to market in the U.S. The size of the migraine market is expected to more than...

Merck said today that the FDA has given consent to review a supplemental Biologics License Application (sBLA) for KEYTRUDA for the treatment of non-Hodgkin lymphoma. http://alph.st/bb41cf87