CEO Heather Bresch talked to Scrip about how she will navigate the company through what has become a rough period for the US generic drug market and validation on complex generics and biosimilars.
Armed with massive amounts of data, China is poised to make a dent in big data-driven innovation and artificial intelligence applications including smart health. A policy push to encourage the development of novel drugs also means there may be more biotech unicorns and innovative therapies to attract investment inflows.
Four health care systems representing 280 hospitals, with input from the US Department of Veterans Affairs, plan to make and sell their own generic drugs, focusing on those vitally needed by hospitals, with "appropriate" pricing.
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Spotlight On J.P. Morgan Healthcare Conference
Biopharma investors were underwhelmed by the deal-making news, but innovation, corporate tax reform and a relatively positive outlook on drug pricing left attendees at the J.P. Morgan Healthcare Conference with the sense that good things are in store for pharma in 2018.
J.P. Morgan Notebook Day 1: Tax Reform At Last, Allergan's Job Cuts, Teva Turnaround, Biogen's Cash, And Getting FDA-Friendly
J.P. Morgan Notebook Day 4: CRISPR's Not Worried; Theratechnologies' HIV Niche; And Is Moderna's IPO Coming Soon?
Daily round-up of news and notes from the 2018 J.P. Morgan Healthcare Conference: Alder's Options for CGRP drug; CRISPR's not worried about Cas9 controversy; Theratechnologies seeks more HIV niche products; Moderna is shaping up to have a big 2018; TG Therapeutics and Immunomedics milestones ahead.
Commercial Explore this Topic
Extending marketing strategies for orphan drugs from the developed world to emerging markets are fraught with difficulty, and pharmaceutical companies need to adapt their business models in such countries for this increasingly popular category of new drugs.
Pooling resources appears key to a major new collaboration in the biosimilars space, between Sandoz and India's Biocon, to develop the next generation of biosimilar immunology and oncology products.
Novartis expected to give Joe Jimenez a good farewell gift; AbbVie says it is not planning major M&A to focus on risankizumab and upadacitinib, but Celgene is on the hunt for deals – will Juno be its next big buy?
Allergan will spend 2018 trying to shift investor focus from the loss of Restasis patent exclusivity in the second half of the year to the company's R&D pipeline, including the late-stage "six stars" highlighted in 2017 and mid-stage programs that are moving into the spotlight.
Privately owned startup OWKIN will use $11m raised in a Series A funding for new hires and building its predictive artificial intelligence platform which it will launch in early 2019 to speed drug discovery.
Dong-A makes notable progress in botanical drug programs, reaching deals for its diabetic neuropathic pain and Alzheimer's disease drug assets with Boston-based NeuroBo Pharmaceuticals.
Strongbridge obtains rights from AEterna Zentaris to first drug approved for adult growth hormone deficiency. While the J.P. Morgan Healthcare Conference didn't have many major deal announcements, there was a flurry of announcements around discovery and development capabilities.
Hudson has gained his footing running Novartis' pharma business. Now, he's preparing to launch seven new drugs by 2020 while growing Cosentyx, Entresto and other in-line products.
Policy & Regulation Explore this Topic
Patent Trial and Appeal Board finds that the patent covering the blockbuster prostate cancer drug is unpatentable, which could allow generics to launch at-risk in October once they obtain FDA approval; at least 12 firms have pending ANDAs.
With an FDA decision on its buprenorphine injection expected by Jan. 19, Scrip spoke with Braeburn executives at J.P. Morgan about the company's justification for four once-weekly and four once-monthly doses, competition in the opioid use disorder (OUD) market and the need for more OUD therapies.
FDA's advisory committee voted down Lipocine's Tlando and Clarus' Jatenzo based on concerns about off-label use, but if they do reach the market, Tlando's lack of titration could pose problems for physicians, while both drugs could raise difficulties with the types of tubing used to test testosterone concentrations.
Now that the European Commission has finally given the go-ahead to Ocrevus, regarded by multiple sclerosis specialists as a game changer especially for the primary progressive form of the disease, observers will be watching to see what pricing strategy Roche adopts.
Research & Development Explore this Topic
Probiodrug believes it can bring success to an Alzheimer's research community that has been hard hit by clinical failures in the last few years – but the company will need a partner or cash influx to take its first-in-class drug through late-stage trials.
Zepsyre did not show a PFS advantage measured against a comparator regimen in platinum-resistant ovarian cancer, but the novel chemotherapy is being tested in nine other cancers.
In a video interview at the Biotech Showcase, Exelixis CEO Michael Morrissey discusses the recent launch of cabozantinib in first-line renal cell carcinoma and looks ahead to filing soon in liver cancer.
As head of AstraZeneca's global research and early development arms Menelas Pangalos has, in the space of eight years, boosted AstraZeneca's pipeline productivity from below industry average to one of the best, at a fraction of the cost. He talked to Scrip about how he effected this transformation using his "5R" framework, and what he needs to do next.
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