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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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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

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

Should Celgene Succumb To The Charms Of Juno?

Observers are weighing up whether it makes sense for Celgene to spend in the region of $12bn and plump for the promise of Juno's CAR-T program and whether it would be forced to abandon another promising partner in bluebird.

M & A Commercial

Korea Stepping Up IO R&D To Catch Up With Global Players, Trends

Immuno-oncology deals and R&D by South Korean companies are picking up speed as they are put more focus on the hot sector in line with global trends.

Commercial ImmunoOncology

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

Merck KGaA Hopes UK Cancer Charity R&D Pact Will Yield New Assets

The multi-project collaboration and licensing deal between charities Cancer Research UK and Germany's Merck aims to discover and commercialize novel cancer treatment assets.

Deals Cancer

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

Glenmark Progresses Novel Pain Asset With Partnering In Mind

Glenmark is moving ahead with studies for its inhibitor of mPGES-1 amid cautious optimism. Pain management is, however, not a core thrust for the Indian firm and it hopes to out-license the potential first-in-class molecule at some stage.

Inflammation Companies

Evox To Raise Cash In 2018 For Novel Exosome Platform

Emerging Company Profile: Evox Therapeutics – a privately held, Oxford-based biotechnology company developing a new class of biotherapeutics called exosomes – is using its technology to improve the delivery of validated therapies, particularly targeting central nervous system and neuromuscular conditions.

StartUps and SMEs Neurology

Merck Hits IO Bullseye With Keytruda Combo In First-line Lung Cancer

Success of Keytruda/chemo combo in KEYNOTE-189 first-line metastatic lung cancer study restores Merck's leadership in immuno-oncology and may drive more use, though doctors are still looking to see more data, especially for PD-L1 subgroups.

Clinical Trials ImmunoOncology
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