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2Q Preview: GSK, Bayer, Celgene, Amgen, AZ, BMS, Sanofi, Merck, Abbvie

GSK, Bayer, Celgene, Amgen, AstraZeneca, Bristol-Myers Squibb, Sanofi, Merck & Co and AbbVie are among the pharma companies due to report second-quarter results imminently. As the financial reporting season moves into a second week, Scrip takes a look at the key things to watch for.

Financial Reports Companies Commercial

Key Clinical Data And Drug Approvals Expected In 2H 2016

As July is already upon us, Scrip takes a look at some of the more interesting clinical trial read-outs and drug approvals expected clinical trials due to report in the second half of the year.

Clinical Trials Approvals BioPharmaceutical

A Peek Into Korean Bioventures’ Success Factors, Challenges

Amid a boom in IPOs and valuations, experts at a recent forum in Seoul took a look at some of the success factors and challenges behind the rapid growth of South Korea’s bioventure sector.

Policy & Regulation Asia Pacific South Korea

Big Data Brings Big Benefits, But Only If Used Properly

Sponsored content by Medidata.

Mobile health is variously described as game-changing and revolutionary in the way it is impacting healthcare.

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Commercial Explore this Topic

Another Black Cloud Douses Valeant's Sunlight

Valeant Pharmaceuticals International Inc. started the week out strong – winning approval to market an oral formulation of Relistor and gaining an FDA advisory committee's backing to sell the company's plaque psoriasis drug brodalumab. But that winning streak came to an abrupt halt with the agency's rejection of the firm's eye treatment latanoprostene bunod.

Companies Commercial BioPharmaceutical

Natco CEO On Dynamics In The HCV Market

Nexavar compulsory license holder Natco Pharma is counted among the leading players in the Indian oncology market and now looks to be aiming for an encore in the hepatitis C segment. Natco vice chair and CEO Rajeev Nannapaneni talks to Scrip of the large patient numbers on HCV therapy and outlines a potential market "split" in certain rest of the world (RoW) territories with the arrival of Gilead's Epclusa.

Commercial Market Access Infectious Diseases

Latest From Commercial

Biocon Stays The Course For Neulasta, Herceptin Biosimilars

Biocon reported robust first-quarter numbers and remains upbeat on the prospects of taking its biosimilars including pegfilgrastim and trastuzumab to Europe and the US notwithstanding regulatory setbacks faced by some seasoned competitors recently.

Financial Reports Biosimilars

IPO Update: Patheon Public Once Again, Audentes To Move Into The Clinic

Two companies in the biopharma space began trading publicly this week, one to pay off debt, the other to fund an early-stage pipeline.

Commercial Business Strategies

China’s First Home Grown Novel HIV Drug Shoots For Prime Time

With a fast-growing HIV population and reliance on older-generation treatments, China could become the next frontier for new antiretroviral drugs. Government support might see the country’s first novel locally developed, long-lasting injectable product take on the big names in the field.

Commercial Infectious Diseases

Deal Watch: Galenica Offers For Relypsa, But Other Suitors May Emerge

Allergan backs out of deal with Adamis for an EpiPen competitor just two months after signing the licensing deal, but before an up-front payment due date kicks in. AbCellera to team with MassBiologics to discover antibodies against drug-resistant Klebsiella infections.

Commercial Deals

Scangos Leaves Biogen Transformed And Transitioning

CEO George Scangos built Biogen into an innovative biotech, but his departure, coming as the company dusts itself off after a fall from glory, increased speculation Biogen could become a takeout target.

BioPharmaceutical Commercial

Remsima Stars In Orion Pharma’s First Half

Sales in Scandinavia of the biosimilar infliximab drove Orion’s specialty business in the first six months of 2016.

Commercial Biosimilars

Policy & Regulation Explore this Topic

Amgen Files Osteoporosis Drug In US Ahead Of Rival Merck

Amgen Inc. and partner UCB Group have filed their osteoporosis drug romosozumab, which is anticipated to drive sales of more than $700m worldwide by 2023, in the US for the treatment of postmenopausal women at risk of fractures.

Commercial Biologics Business Strategies

Suicide Warnings For Valeant’s Siliq Could Hinder Access To Psoriasis Treatment

While an FDA advisory committee unanimously supported approval of the plaque psoriasis drug brodalumab, several recommended a black box warning on suicide risk that could limit sales of the drug.

Advisory Committees Policy & Regulation Risk Management

Latest From Policy & Regulation

Valeant’s Oral Relistor Poised To Face-Off Against AstraZeneca’s Movantik

FDA approval of the first oral form of Valeant’s mu-opioid receptor antagonist Relistor will pit the franchise against Movantik for the treatment of patients with opioid-induced constipation with non-cancer pain.

Approvals Commercial

Sandoz's Biosimilar Rejection Ups Risks, But Won't Kill Market

The FDA's rejection of Sandoz Inc.'s version of Amgen's Neulasta (pegfilgrastim) has revealed the hard truth that chasing the biosimilar market may be a riskier and more costly endeavor than companies anticipated.

Companies Biosimilars

Emerging Diseases: Disruptive, Commercially Risky, But GSK Has A Solution

GlaxoSmithKline PLC has offered up its new Maryland vaccine research and development center, and its scientists, under the company's proposal to establish a global collaboration for the pursuit of products that are commercially risky, but necessary to address emerging infectious diseases, before a public health crisis strikes.

Companies Clinical R&D

More Valeant Humiliation: Will The Messiness Ever End?

Valeant experienced more humiliation last week, with Sequoia Fund completely exiting its position, the former CEO dumping about 5 million shares and the FDA raising suicide concerns with brodalumab, likely limiting its market potential.

Commercial Companies

FDA To Join The 'Real World' Under PDUFA VI

Under round six of the user fee agreement with industry, the FDA is pledging to explore the use of real-world evidence, strengthen the patient's voice in the drug review process and boost the agency's postmarketing surveillance abilities.

Commercial Policy & Regulation

Santhera Setback Could Have Wide-Reaching Effects For DMD Drugs

The DMD community faces another setback as FDA pushes back timelines for Santhera and its respiratory drug, pushing the market to question what will come for other DMD treatments in development.

BioPharmaceutical Companies

Clinical / R&D Explore this Topic

PIPELINE WATCH: Eight Approvals, Seven Filings And Three Launches

This week's Pipeline Watch, a snapshot of all the late-stage R&D and regulatory events in the pharma and biotech industries, is now available to view.

Clinical R&D Pipeline Watch Approvals

Huapont Taps US Partner To Ride China Precision Medicine Wave

2016 is the year for precision medicine therapies to be included in China’s National Major Project for Innovation. Looking to seize market opportunity in the newly funded area, Huapont Life Sciences has linked up with and invested in a US bioventure partner for a gene therapy for refractory angina.

Clinical R&D Companies China

Latest From Clinical R&D

Changes Brewing At Bayer, But Pharma Strategy Remains On Point

Bayer AG is pursuing an acquisition of seed manufacturer Monsanto Co. that would establish agriculture as the largest business unit within the diversified life sciences company, usurping pharmaceuticals as the top revenue generator. Bayer Head of Innovation Kemal Malik said the company’s commitment to pharmaceuticals remains unwavering despite the M&A play.

Business Models Clinical R&D

Zafgen Drops Beloranib, But Its New Focus Raises Doubts

The biotech is shifting gears after clinical hold on its lead drug was unlikely to be lifted, but the early-stage candidate that it's placing its hopes on is raising red flags for analysts and investors.

Commercial Business Strategies

XBiotech Stands By Advanced Colorectal Cancer Phase III Study

The Austin, Texas-based biotech XBiotech has stood by its clinical trial strategy in critically-ill colorectal cancer patients, that could lead to the relatively rapid assessment of cancer agents in this group of patients, including the assessment of its lead product, the anti-IL-1 alpha monoclonal antibody, Xilonix.

Clinical R&D Companies

Update: Ziopharm Study Death Not Due To Drug

The biotech confirmed that a recent death during a clinical trial was not caused by its early-stage gene therapy.

Clinical R&D Companies

Emerging Diseases: Disruptive, Commercially Risky, But GSK Has A Solution

GlaxoSmithKline PLC has offered up its new Maryland vaccine research and development center, and its scientists, under the company's proposal to establish a global collaboration for the pursuit of products that are commercially risky, but necessary to address emerging infectious diseases, before a public health crisis strikes.

Companies Clinical R&D

Positive Tagrisso Data Boost AstraZeneca's Lung Cancer Ambitions

Latest data from AstraZeneca's Tagrisso will help the company to convert the lung cancer drug's conditional approvals to full approvals, and boost reimbursement negotiations.

BioPharmaceutical Clinical R&D
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