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ENDPOINTS 01/17/2020 10:41
→ Peter Ciriello to the upper echelons of the French medical device maker Vygon Group. He will run the company’s US operations from the company’s headquarters in Pennsylvania and is also tasked with overseeing activities at the New Hampshire facility. Ciriello joined Vygon in 2018 and takes over from Les Davies, who served as CEO, Vygon UK and VP for the UK/North American region. Ciriello previously served as co-founder and managing partner at Clearwater Organic Farms. → After regaining two liver disease drugs from Shire and making its public debut with a $67.3 million IPO, Mirum Pharmaceuticals SVP, finance of communications Ian Clements to CFO. Clements joined the company in May 2019 after a stint as VP of investor relations at Dermira .
ENDPOINTS 01/17/2020 09:56
→ The first drugmaker to win approval for a NASH therapeutic is going to have to wait three months longer. The FDA is now expected to make its final decision on Intercept Pharmaceuticals ‘ obeticholic acid by June 26. The delay was attributed to a major amendment — additional information was provided by the company in response to FDA requests — as well as to accommodate an advisory committee meeting, Intercept said in a on Friday. Last month, the FDA notified the company it tentatively intended to hold the adcomm on April 22 — so a delay to the March PDUFA was in any case expected. → This week, the EMA’s safety committee recommended of Danish drugmaker LEO Pharma ‘s gel Picato. Patients should stop using the therapy — which is approved to t.
ENDPOINTS 01/17/2020 09:11
Novo Nordisk’s blockbuster weekly injectable formulation of semaglutide — Ozempic — has secured an formidable label — apart from its ability to stimulate insulin production in patients with diabetes, the FDA has now also endorsed its ability to reduce the risk of major adverse cardiovascular events. Patients with diabetes are often afflicted with other comorbidities, such as obesity, CV disease, and kidney problems.
ENDPOINTS 01/17/2020 07:32
Joshua Smiley Lilly. By delivering the only M&A news in a relatively muted deal scene at JP Morgan, Eli Lilly distinguished itself as an active buyer right at the start of the year. And, according to its CFO, you can expect more to come in the year ahead. Lilly kicked off the annual confab — prime time for Big Pharma players to stake their claims in key areas — on the Friday before the action got going in San Francisco with the announcement that it’s bagging Dermira for . The biotech had a commercial product and a suite of preclinical dermatology programs, but the crown jewel was undoubtedly the late-stage IL-13 drug lebrikizumab. Josh Bilenker. “We are looking at Dermira-like opportunities targeting assets in the $1 billion to $5 billion ran.
ENDPOINTS 01/17/2020 07:24
The first Chinese biotech to list on the Nasdaq in over two years will do so with a splash. Oncology and autoimmune-focused I-Mab will raise $104 million in its IPO as it prices at $14 per share, toward the high end of a $12-$15 range. That’ll put it just a couple rungs behind the $150-million-plus raised in 2017 by Zai Labs, a highly regarded pioneer of the model I-Mab is now following: licensing US drugs and introducing them to China. The haul underscores the growing prominence of a Chinese biotech industry and the amount investors are willing to shell out for promising assets in oncology, where its fastest innovation and greatest profit over the last half-decade. Around a dozen Chinese biotechs have chosen to go public in Hong Kong in re.
ENDPOINTS 01/17/2020 06:23
A split advisory panel vote on Durect’s non-opioid drug to manage post-surgical pain is only going to make the FDA’s task harder. After FDA staff reviewers issued an that underscored their unease with the side effect profile of the long-acting anesthetic posimir — on Thursday a panel of independent experts could not reach a consensus on whether to back the therapy. Six panelists endorsed approval, while the remaining six did not back the therapy, a formulation of bupivacaine designed to manage pain up to three days following surgery after being administered directly into the surgical incision. Posimir has a checkered past.
ENDPOINTS 01/16/2020 17:48
Robert Baffi BioMarin. SAN FRANCISCO — BioMarin got some considerable attention from the Wall Street Journal today with its revelation that CEO JJ Bienaimé has been thinking about charging $2 million to $3 million for the company’s new gene therapy for hemophilia A, valrox, which is the lead drug in the race for a pioneering FDA approval. It’s an important discussion, and we’re glad to in the gray lady of Street speak, which has a big reach.
ENDPOINTS 01/16/2020 11:17
Paul Hudson. SAN FRANCISCO — Sanofi CEO Paul Hudson spent zero seconds of his presentation talking about a cardiovascular drug his company spent years developing. Robert Bradway of Amgen, the company whose rival product was so formidable Sanofi and their partner Regeneron spent $67.5 million on a priority review voucher to get theirs approved faster, barely touched on the drug.
ENDPOINTS 01/16/2020 10:50
→ Mayo Clinic is opening up its sprawling clinical database to nference , the Cambridge, MA-based AI startup it’s long partnered with and recently backed in a round. The project aims to digitize 25 million tissue slides within the next 2 to 2.5 years, FierceBiotech , in addition to annotating, linking and tagging written physician notes. After sorting through the data, nference will use the platform to identify new targets and biomarkers as well as apply it in clinical trial recruitment and real-world evidence generation. → Cyprium Therapeutics , one of the startups incubated by Fortress Biotech, rare pediatric disease designation by the FDA for copper histidinate, also referred to as CUTX-101 , for the treatment of Menkes disease. The drug.
ENDPOINTS 01/16/2020 09:34
Nick Galakatos Blackstone. Seven months after Olivier Brandicourt’s surprise from Sanofi, he’s back in the game, this time taking meetings at JP Morgan to discuss his new role at Blackstone, where he’s quietly begun work with Nick Galakatos and the life sciences crew. Brandicourt’s new — though still unannounced — career in private equity comes as Galakatos and others at Blackstone are rounding up the last of the cash needed for a monster, .
ENDPOINTS 01/16/2020 09:00
The team at Frazier Healthcare did a number of deals that exemplified its wide-ranging strategy in 2019: Tachi Yamada worked with gene therapy pioneer Jim Wilson to ; Mike Gallatin and its STING-targeted small molecule ; and Bhaskar Chaudhuri flipped just months after introducing it to the world via a crossover round close to $100 million.
ENDPOINTS 01/16/2020 07:53
As international relations experts continue to cast skepticism on the "phase one" US-China trade deal signed Wednesday, multinational drugmakers found much to be cheerful about. Specifically, the includes three provisions related to pharmaceutical patent dispute resolution, patent term extension and counterfeit medicines, promising to strengthen protection for drugs at a time China’s regulatory agency has sped up reviews and shortened the time gap between overseas and Chinese OKs. Very nice rally in China bio stocks last night on the IP news from the trade war.
ENDPOINTS 01/16/2020 07:44
As some insulin, human growth hormone and other products transition on 23 March from new drug applications (NDAs) to biologics license applications (BLAs), the recently passed government spending bill included a further tweak to add new proteins to the transition. The NDA to BLA change effectively means that any follow-on products for these NDAs will need to win approval as biosimilars after March.
ENDPOINTS 01/16/2020 06:03
It appears GSK and Pfizer — who run a consumer health JV together — forgot to get their story straight ahead of the JP Morgan conference. On Tuesday, Pfizer chief Albert Bourla he expected the JV’s majority owner GSK to work toward an IPO within three to four years. David Redfern. The following day, GSK’s chief strategy officer David Redfern told Bloomberg that the consumer business needs to consolidate and grow and that an IPO isn’t the only viable option. "Actually we haven’t decided anything," he said.
ENDPOINTS 01/15/2020 11:49
On Monday, we held our fourth annual #JPM event — and the team hit a key milestone that I’d like to share with the entire Endpoints News audience: We live-streamed the conversation and had nearly triple the number of executives watching online than we had in the sold-out crowd of 320. For a media company on a mission to connect the biopharma world in bigger and better ways, we’re proud of how we were able to extend the reach of our franchise event.

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