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Mylan CEO Heather Bresch On How Mylan Is Different Than Teva

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.

Generic Drugs Biosimilars Business Strategies

China In 2018: Watch Out For AI, CAR-T And Biotech Unicorns

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.

Platform Technologies ImmunoOncology Asia Pacific

Provider Consortium Will Try 'DIY' Solution To Generic Shortages, Pricing

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.

Generic Drugs Pricing Debate Strategy

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Commercial Explore this Topic

Companies Urged To Tailor Approach To Orphan Drugs In Emerging Markets

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.

Rare Diseases Emerging Markets Commercial

Riding The Next Wave Of Biosimilars: Sandoz To Link Up With India's Biocon

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.

Biosimilars Deals Commercial

Pharma Q4 Results Preview: J&J, Novartis, Celgene, Biogen & AbbVie

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?

Sales & Earnings M & A

Allergan Relying On 'Six Stars' And Other R&D Programs To Blunt Restasis Blow

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.

Business Strategies Research and Development Strategies

OWKIN CEO Outlines AI's 'Transfer Learning' Promise In Drug Discovery

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.

Business Strategies Commercial

Dong-A Ties With NeuroBo For Diabetic Neuropathy, Alzheimer's

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.

Commercial Deals

Deal Watch: From The Sidelines Of J.P. Morgan, Lots Of Discovery Deals

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.

Deals Business Strategies

Novartis Pharma CEO Paul Hudson Discusses Leadership And Launches

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.

Business Strategies Launches

Policy & Regulation Explore this Topic

PTAB Clears Path For Earlier Generic Zytiga Launch

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.

Policy Intellectual Property Legal Issues

Braeburn's Buprenorphine Bid: Eight Dosing Options Part Of "All Hands On Deck" Approach

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.

Approvals Business Strategies

Oral Testosterone Therapies Face Clinical Practice Difficulties, Advisory Panels Suggest

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.

Advisory Committees Regulation

All Systems Go as Roche MS Drug Ocrevus Secures EU Okay At Last

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.

Approvals Neurology

Research & Development Explore this Topic

Could Probiodrug Represent A New Era Of Alzheimer's R&D Progress?

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.

Business Strategies Neurology Market Intelligence

PharmaMar Endures Second Recent Setback With Phase III Ovarian Cancer Failure

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.

Clinical Trials Cancer

Exelixis CEO Eyes Expanded Indications For Cabozantinib

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.

ImmunoOncology Clinical Trials

AstraZeneca's Pangalos On How He Turned Around R&D Productivity

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.

Companies Leadership