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ENDPOINTS 09/13/2019 18:11
After a fairly from FDA staff on Wednesday, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS). Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified.
ENDPOINTS 09/13/2019 10:27
→ Neil Woodford ‘s investment trust was forced to write down the value of one its holdings by just under $40 million, another tumble in what’s become a long-running landslide for the once marquee firm. Once one of Britain’s most successful stock pickers and a prominent supporter of the nation’s biotech industry, Woodford has found himself in the crosshair s since he suspended the Equity Income Fund after years of underperformance and months of massive withdrawals. The name of the written-down holding is yet to be announced. → Novartis from its Phase III ASCLEPIOS I and II studies, which compared the efficacy of ofatumumab (a fully human anti-CD20 monoclonal antibody) to Aubagio in patients with multiple sclerosis (MS) — results showed ofatu.
ENDPOINTS 09/13/2019 10:18
More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed. Andrew Ritter. This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value
ENDPOINTS 09/13/2019 10:11
An early-stage update on Adverum Biotechnologies’ intravitreal gene therapy has triggered investor concern, after patients with wet age-related macular degeneration (AMD) saw their vision deteriorate, despite signs that the treatment is improving retinal anatomy. Adverum, on Wednesday, from the OPTIC trial of its experimental therapy,. ADVM. -022, in six patients who have been administered with one dose of the therapy.
ENDPOINTS 09/13/2019 08:39
In the first of what it hopes will be a couple of major regulatory milestones for its new drug, Ardelyx has bagged an FDA approval to market Ibsrela (tenapanor) for irritable bowel syndrome. The drug’s first application will be for IBS with constipation (IBS-C), inhibiting sodium-hydrogen exchanger NHE3 in the GI tract in such a way as to increase bowel movements and decrease abdominal pain.
ENDPOINTS 09/13/2019 08:33
Months after analysts and investors called on Biogen and Eisai to for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety. BACE has been the most thoroughly disproved approach in all of Alzheimer’s R&D, with decisive Phase III failures at , , and then Amgen/Novartis. The last big failure arrived a few months ago, when two pivotal Phase II/III trials of the BACE1 drug CNP520 (umibecestat) — undertaken with the Banner Alzheimer’s Institute. Investigators concluded in an interim review that patients taking their drug experienced a worsening
ENDPOINTS 09/13/2019 08:04
Cystic fibrosis (CF) drug maker Vertex Pharmaceuticals — which is still locked in negotiation with NHS England to endorse the use of its medicines — has convinced Scotland’s authorities to utilize its medicines. A month ago, the Scottish Medicines Consortium two of the company’s medicines — Orkambi and Symkevi — citing uncertainty over their long-term efficacy in relation to their cost. Each drug carries a list price of more than £100,000 per patient per year.
ENDPOINTS 09/13/2019 07:00
As a widely recognized biotech hub, Boston is undoubtedly one of the best places to start a new company at the frontier of biology and engineering. With a dense network of incubators, venture capitalists and talent, seasoned company founders can have their pick of partners and models launching their latest startups. But for young, aspiring entrepreneurs, it’s a very different scene. Big VC firms might hire you to work on their ideas instead of yours, and accelerators may not offer the kind of deep technical expertise and guidance needed to make it in the field. “There was no formal path, and really, there was no ecosystem,” Brian Baynes recalled about joining Flagship Pioneering 15 years ago, fresh out of his PhD program, after finding “tha.
ENDPOINTS 09/13/2019 06:37
In April, Castle Creek swooped in to with the embattled gene and cell therapy Fibrocell to shepherd its lead gene therapy for a type of “butterfly” disease into late-stage development. Now, the New Jersey-based dermatology company is acquiring its partner in a deal worth $63.3 million. Castle Creek CEO Greg Wujek. Pennsylvania-based Fibrocell last year initiated a review of , including a sale. Its lead drug FCX-007 is engineered to treat the underlying cause of recessive dystrophic epidermolysis bullosa, which is caused by the deficiency of the protein COL7. Cells are extracted from the patient, genetically modified, and then used to treat wounds by local injection, avoiding systemic distribution. A late-stage study for FCX-007 was kicked of.
ENDPOINTS 09/13/2019 06:02
SpringWorks Therapeutics’ IPO has delivered a bounty — upsized from its original $115 million pitch — in a resounding endorsement for Bain’s Big Pharma spinout model for biotech creation. Meanwhile Satsuma Pharmaceuticals, a San Francisco fledgling hatched by Japan’s Shin Nippon Biomedical Laboratories, is reaping $83 million in its public debut. Both companies on the same day and ended up upsizing their offers. Saqib Islam. For SpringWorks, which priced 9 million shares at $18 each topping the range, the new infusion will supplement its already impressive cash pile, with $185.3 million still intact out of $228 million raised.
ENDPOINTS 09/12/2019 20:29
Big Pharma just struck its second distribution deal with the growing global medical marijuana business. Nine months after Novartis’ Sandoz group , the medical cannabis grower Canndoc says it will use Teva’s SLE group to distribute its medical cannabis products in Israel, and then spearhead the global distribution of its products to markets around the world where medical cannabis is legal. “Through its SLE partnership, Canndoc has aligned itself with one of the most prominent pharmaceutical companies in the world, for the distribution of cannabis-based medical treatments to countries that recognize the value of these medicines for people in need,” noted company chairman Ehud Barak in a statement. Barak is the former prime minister of Israel,
ENDPOINTS 09/12/2019 16:08
Investigators involved in developing a ⭐⭐⭐⭐ cancer drug tapped as a bright prospect in Amgen’s early stage oncology pipeline have halted enrollment of new patients after signs of “cardiac toxicity” at a related drug with the same mechanism raised safety concerns at the FDA, prompting a clinical hold. Geoffrey Porges. The pharma giant noted in an oncology update that their dose ranging study of the MCL1 inhibitor AMG 397 was placed on clinical hold by the agency, which prompted researchers to voluntarily halt enrollment in another early study of their other, more advanced, MCL1 program for AMG 176. The news attracted the attention of SVB Leerink’s Geoff Porges, who had tapped AMG 176 as a 4-star opportunity — on his 5-star scale, with 5 being.
ENDPOINTS 09/12/2019 10:25
→ After welcoming J&J dealmaker to their team as BD chief a little more than a week ago, Bayer that it will be reducing the size of the company’s board of management. Hartmut Klusik and Kemal Malik will be hitting the exit and the company doesn’t plan on retaining those positions — taking the board from seven to five members. According to the company, as of January 1, 2020, the board of management will consist of chairman Werner Baumann , CFO Wolfgang Nickl and division presidents Liam Condon (Crop Science), Stefan Oelrich (Pharmaceuticals) and Heiko Schipper (Consumer Health). →Bain-backed Pfizer spinout SpringWorks Therapeutics is the proposed deal size for its upcoming IPO after its intention to reap a large windfall of $115 million to a.
ENDPOINTS 09/12/2019 10:16
It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties. His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure. The Times coverage noted that DeAngelis sought to assure staffers that MSK recognized their concerns, but added that she was quick to.

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