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Stronger Together: Pfizer Decides Against A Split

The pharma giant's decision not to break up into two separate publicly traded companies as it has been contemplating for several years reflects an improved growth outlook and the inability to unlock trapped value. Now Pfizer can finally get on with business.

Business Strategies Business Models Financial Strategies

Profile: GSK's Mature Products Head Says Innovation Still Possible In Established Drugs Business

Seasoned generics and intellectual property expert Richard Saynor went from poacher to game keeper when he became head of GlaxoSmithKline PLC's established products portfolio – tasked with growing the company’s aging assets in new markets and protecting them from erosion by new generic options.

Business Strategies Market Intelligence Commercial

New Interim CAR-T Data Support Kite’s BLA Submission Plans

Kite Pharma Inc. executives reiterated plans on Sept. 26 to pursue US FDA approval this year for the chimeric antigen receptor T cell (CAR-T) therapy known as KTE-C19, keeping the company on track to seek accelerated approval for a form of advanced lymphoma before any of its competitors.

Clinical R and D Companies BioPharmaceutical

Glass Ceiling Cracked; Pharma Forges Path To Gender Equality By 2040?

One woman CEO is an improvement, but at this rate gender equality won't arrive before immuno-oncology goes generic.

Business Strategies Leadership People
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Commercial Explore this Topic

Stockwatch: Fanning The Embers Of M&A

A drug approval at Sarepta, two acquisitions by Allergan and $15bn worth of dry powder at Takeda has prompted “biotech off to the races” commentaries by analysts and the press. This froth will probably dissipate.

M and A Commercial Approvals

Interview: German Merck Set For Big "Leap" In India

Germany's Merck Group appears set to build on its strong showing in India. Belén Garijo, CEO of Healthcare at Merck KGAA, tells Scrip about efforts to "consumerize" the firm's primary care business, how Erbitux is the "backbone" on which the company will build its oncology presence, and plans to roll out new products including the clinical stage immune-oncology asset avelumab, in India.

Commercial Strategy India

Latest From Commercial

GSK's Immunology Strategy Edges Closer To Delivering

GlaxoSmithKline is working to establish an immuno-inflammation portfolio and extend learnings to other therapy areas. Sirukumab could be GSK's first new product in I&I beyond Benlysta. Chief Immunology Officer Paul-Peter Tak outlined his strategy in an interview with Scrip.

Immune Disorders Business Strategies

Amgen's Kyprolis Miss In First-Line Myeloma Surprising, But Clinically Irrelevant

Because CLARION was designed to test Kyprolis head-to-head against fellow proteasome inhibitor Velcade, the failure could hurt the drug's standing in its class. But the trial design used a regimen largely phased out of clinical practice and Amgen has other chances to prove superiority.

Cancer Market Access

Indian Teneligliptin Saga: Brands Bazaar, Surging Volumes

More than two dozen brands, a sharp spurt in sales volumes and a price decline of over 60% currently appear to characterize the market for the type 2 diabetes therapy teneligliptin in India. And market watchers claim that teneligliptin volumes in the country have surpassed the combined numbers of some of the more established gliptins, including vildagliptin and sitagliptin.

Commercial Market Intelligence

Interview: Strategies For Bio Manufacturing Partnerships

Boehringer Ingelheim’s head of BioXcellence, its contract manufacturing business, talks to Scrip about best practice when forming a long-term relationship with an outsourcing services provider.

BioPharmaceutical Manufacturing

Brexit: Issues and Opportunities As UK Life Sciences Define A New Relationship In Europe

It's fair to say that the outcome of the June 23, 2016 referendum on the UK’s membership of the EU stunned not only the nation, whether you voted to leave or remain, but sent shockwaves through Europe and beyond. The UK’s pharmaceutical industry made no secret of its stance: it was all about remain – but it got a Brexit. Scrip’s Sukaina Virji gathered a group of pharma industry experts who had spent their summer working on making the best of the situation. Here’s an edited recount of their insightful discussion.

Brexit Commercial

New Crohn’s Indication Puts Janssen’s Stelara On Equal Ground With Anti-TNFs

J&J’s Janssen Biotech subsidiary won FDA approval for the IL-12/IL-23 inhibitor Stelara to treat Crohn’s disease, giving it a second-line position alongside anti-TNF therapies for patients in need of new options.

Product Approvals Pricing Reimbursement

Policy & Regulation Explore this Topic

Amgen's Amjevita Approved As First Biosimilar To AbbVie's Humira

Company starts "a new chapter" with the first approval out of its biosimilar pipeline, which happens to be for the biggest drug in the world.

Approvals Biosimilars United States

Daiichi’s Japan Filing The First For Denosumab In RA

Daiichi Sankyo has filed for the approval in Japan of denosumab for rheumatoid arthritis, marking the first such filing for the Amgen-originated antibody in this setting.

Japan Clinical R and D Clinical Trials

Latest From Policy and Regulation

What’s A Fair Price For A Biosimilar In Europe?

The views of biosimilar manufacturers and payers in Europe still vary widely as to what a “fair price” for a biosimilar should be, what discounts should be offered and when, and how to determine what is an appropriate return on investment, says a new report from Simon Kucher & Partners.

Biosimilars Europe

New Crohn’s Indication Puts Janssen’s Stelara On Equal Ground With Anti-TNFs

J&J’s Janssen Biotech subsidiary won FDA approval for the IL-12/IL-23 inhibitor Stelara to treat Crohn’s disease, giving it a second-line position alongside anti-TNF therapies for patients in need of new options.

Product Approvals Pricing Reimbursement

Jim O’Neill Is “Free For Global AMR Role” After Leaving UK Government

Having suddenly resigned from the UK Government Jim O’Neill says he’s now available to take on a global role, if asked, to promote concrete action on tackling antimicrobial resistance within promised timeframes.

United Kingdom Policy and Regulation

How Many Pricing Hearings Add Up To Action On Pricing Transparency?

Mylan’s discussion of how the drug supply chain absorbs pricing for EpiPen raised more questions than it answered during a House Oversight Committee hearing

Legislation Pricing Debate

Duchenne Surprise: Sarepta Prices Exondys 51 Below Expectations

It sparked at least one analyst to question how Sarepta came up with a price for FDA's first approved Duchenne muscular dystrophy treatment.

Approvals Drug Review

Takeda's Ninlaro Back In European Myeloma Race After CHMP Turnaround

A CHMP about turn on Takeda's Ninlaro (ixazomib) for multiple myeloma means the Japanese firm is back on track to compensate for lost revenues from the impending patent expiry of key product Velcade. However, the Japanese firm will have a tough time ensuring Ninlaro is not overshadowed by rivals.

Approvals Cancer

Clinical / R&D Explore this Topic

DMD Pipeline: After Sarepta’s First-Ever Approval, Are Combinations Next?

Several companies have DMD drug candidates waiting in the wings to follow Sarepta’s Exondys 51 into the commercial market after FDA approval of the exon-skipping therapy, which could be the backbone for future combination treatment regimens.

Research and Development Strategies Neurology Regulatory

Promising Tanibirumab Trial Boosts PharmAbcine’s Confidence

PharmAbcine is counting on the success of its lead anticancer antibody tanibirumab following promising early Phase II results, and the South Korean bioventure is planning to raise new funds as it looks to progress this and other pipeline projects.

South Korea Business Strategies BioPharmaceutical

Latest From Clinical R and D

Array Rises As COLUMBUS Clears Phase III Melanoma Hurdle

Shares in Array Biopharma shot up by more than 80% on the release of top-line Phase III data from its COLUMBUS study of encorafenib and binimetinib, but more details are needed to gauge how the combination may fare against Novartis and Roche’s more established combos, and the newer IO therapies.

Cancer Clinical Trials

GSK's Immunology Strategy Edges Closer To Delivering

GlaxoSmithKline is working to establish an immuno-inflammation portfolio and extend learnings to other therapy areas. Sirukumab could be GSK's first new product in I&I beyond Benlysta. Chief Immunology Officer Paul-Peter Tak outlined his strategy in an interview with Scrip.

Immune Disorders Business Strategies

Dravet Syndrome Indication Will Set GW Pharma Apart On US Epilepsy Market

GW Pharma is on track for 2017 filings for its marijuana-derived epilepsy therapy, Epidiolex (cannabidiol), following more positive data from the third Phase III study for the drug to be presented this year – however, Epidiolex's potential in Dravet syndrome will be its competitive edge to set GW apart from rivals.

Neurology Clinical Trials

INFOGRAPHIC: Heart Failure, A Growing Market

Heart failure is currently one of the most common reasons for hospitalization amongst people over 65 years of age. Causes of heart failure include atrial fibrillation, an erratic rhythm of the heart, and high blood pressure.

BioPharmaceutical Clinical R and D

GtreeBNT Aims To Validate Business Model Via Licensing Deals

2017 may be a milestone year for GtreeBNT as it progresses its late clinical stage pipeline in the US for various high-need indications including glioblastoma, the South Korean bioventure’s CEO assuring investors that he expects to see “good results” in the near future as it seeks licensing deals for its assets.

Clinical R and D Business Strategies

Novartis Sees Disruptive Potential For Novel Malaria Drug

Encouraging early data for a first-in-class anti-malarial from Novartis suggest it is effective against the two major malaria parasites and could be a “game-changer” in the disease.

Asia Clinical R and D
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