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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 Business Strategies

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 Research and Development Strategies

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 Companies
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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 Cancer

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 Companies

Better Together: BioCryst, Idera Merge To Improve Rare Disease Position

New company will have pair of Phase III candidates, an immuno-oncology licensing opportunity, strong experience in hereditary angioedema and roughly $243m in cash to position itself as a rare disease stronghold.

M & A Rare Diseases

Bioverativ: More Than Just A Hemophilia Company

The blood disease specialist, to be acquired by Sanofi, is best known for its two marketed hemophilia drugs, but Bioverativ spent 2017 working on business development and diversifying beyond hemophilia. Scrip talked to CEO John Cox about the pipeline just before the merger was announced.

Business Strategies M & A

Sanofi Builds Blood Disorder Specialty With Bioverativ Buy

The French drug maker is making a big splash into blood disorders with the $11.6bn acquisition of hemophilia specialist Bioverativ. Eloctate and Alprolix are young and growing brands, but the competition in hemophilia is fierce, which means Bioverativ's pipeline will also need to deliver to justify the premium price.

M & A Rare Diseases

Which Biotechs Enjoyed A 'JPM Jump' - And Which Lost Out?

As participants from this year’s J.P. Morgan Healthcare conference recover from the torrent of new information they were exposed to, Scrip explores which biotechs saw a sustainable shift in their valuations.

Commercial Companies

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

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

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

Amgen Wins First EU Avastin Biosimilar Approval, But When Will It Launch?

Partners Amgen and Allergan have become the first biosimilar developers to win EU approval for a copycat version of Roche's Avastin; commercialization preparation is underway but predicting a launch date for the product is more complicated.

EU Approvals

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

Research & Development Explore this Topic

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 Research and Development Strategies

Exelixis' CELESTIAL Liver Trial Succeeds, But Can Cabozantinib Compete?

CELESTIAL second-line liver cancer study is positive, but 4% response rate pales in comparison to PD-1 performance of Bristol's Opdivo and Merck's Keytruda.

Clinical Trials Research & Development

Bioverativ: More Than Just A Hemophilia Company

The blood disease specialist, to be acquired by Sanofi, is best known for its two marketed hemophilia drugs, but Bioverativ spent 2017 working on business development and diversifying beyond hemophilia. Scrip talked to CEO John Cox about the pipeline just before the merger was announced.

Business Strategies M & A

Astellas' ASP0113 Trial Failure Gives Merck's Prevymis Further CMV Boost

Merck's Prevymis should benefit from the failure of ASP0113 in a late-stage trial treating cytomegalovirus in certain kidney transplant patients.

Business Strategies Vaccines
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