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Merck's New Pricing Pledge Shows Style Over Substance
A 60% price reduction on hepatitis C drug Zepatier sounds impressive, but the drug has been declining and the HCV space overall is shrinking. Another set of 10% reductions come on small-sellers that are now generic.
FDA Commissioner’s Rx For US Biosimilars Market: Reform Contracting Practices And Payment Models
In unveiling the agency’s Biosimilar Action Plan, FDA's Gottlieb continued his pattern of provocative remarks by criticizing brand company practices and payment models that impede biosimilar competition and could ultimately undermine innovation. He also called for more action by the Federal Trade Commission and downplayed the impact interchangeability could have on biosimilar uptake.
Allergan's Abicipar Effective With Fewer Injections, But More Inflammation In AMD
Allergan and Molecular Partners said dosing of the VEGF inhibitor every eight or 12 weeks was non-inferior to Lucentis every four weeks. But while AMD patients would enjoy fewer sharp pokes in the eye, about 15% may experience inflammation – at least until a new formulation is available.
Pharma's 2018 Deal-Making Story, So Far
Pharma has been busy making deals this year, while the political winds of change swirl overhead, as our infographic shows. Companies both big and small have been merging to carve out therapeutic niches, return value to shareholders, and position themselves for the next wave of innovation and change.
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Innovation in the pharmaceutical industry has never been more exciting, and complicated. Disruptive technologies, such as artificial intelligence and digital health tools, and advanced therapeutic modalities including cell and gene therapies and antisense oligonucleotides demand that all health care stakeholders make efforts to move into the next generation of patient care and centricity.
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BLH Launch Excellence Survey
Pharma Intelligence in partnership with Blue Latitude Health is undertaking a survey to gather insight on the drivers, barriers, and trends of Launch Excellence in modern healthcare environment. Take this 5-10 minute survey and help shape the future of launch excellence. To show our appreciation for your time, each respondent to complete the survey will be entered in a draw to win one of four $100 Amazon gift cards.
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Novartis Pushes Dermatology Momentum By Licensing Atopic Dermatitis MAb
Novartis is hoping to use its considerable Cosentyx sales slipstream and internal dermatology engine to develop its next skin success by licensing-in a novel antibody against IL-17C from Galapagos and MorphoSys.
MaxCyte CEO Says FDA OK Of IND For Its CAR Receptor Candidate Major Milestone
MaxCyte's first next-generation chimeric antigen receptor MCY-M11 will be studied in solid tumors.
Tibsovo Approval Makes Agios’ Second AML Approval In A Year; Priced At $26k For 30 Days
Tibsovo is the second targeted therapy approved for a mutation-specific subset of relapsed/refractory AML patients. Agios discovered and jointly markets the first, Idhifa, with Celgene.
Deal Watch: Gilead Continues To Add To IO Armamentarium In Collaboration With Gadeta
Deal through Kite Pharma subsidiary focuses on developing gamma delta T-cell receptor therapies. Sanofi inks SHP2 cancer collaboration with Revolution, while Vical considers its strategic options.
Strong Sobi With New Asset: A Takeover Target For Sanofi?
Swedish rare diseases specialist Sobi has reported strong financials and the acquisition of a rare disease candidate on the verge of US approval. Could partner Sanofi pop the question soon?
Pharma Q2 Results Preview: Lilly, Biogen, GSK And Gilead
Key strategy updates are coming: GSK will unveil its new R&D approach, Biogen will update investors on its Alzheimer's plans, and investors are keen to find out whether or not Lilly will sell its animal health franchise. Investors will also be keeping an eye on how Gilead is faring with its move into oncology.
PureTech’s Milk Exosome-Based Technology Draws R&D Pact With Roche
PureTech's milk-derived exosome platform will be used by Roche to generate numerous novel antisense oligonucleotides, potentially earning PureTech more than $1bn in milestone and royalty payments.
Mehta Analysis: China, A Populist Pharma Power
With money pouring into biopharma in China, and regulatory reforms favoring market growth and R&D speed, western firms should watch their backs, warns Viren Mehta, founding partner of Mehta Partners LLC.
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Beyond Rebates: PhRMA Wants HHS To ‘De-Link’ Supply Chain Compensation From List Price
Focus should not be limited to rebates in Medicare Part D, manufacturers advise in comments on HHS drug pricing blueprint. Pharmacy benefit managers raise anti-trust issues with shift to upfront discounts.
Mehta Analysis: China, A Populist Pharma Power
With money pouring into biopharma in China, and regulatory reforms favoring market growth and R&D speed, western firms should watch their backs, warns Viren Mehta, founding partner of Mehta Partners LLC.
Korea Eyes New Consortium To Support Innovation, Nurture Biotech Hubs
South Korea moves to support open innovation in the pharma and biotech industries, and to raise global competitiveness of biotech clusters in the country, in an effort to catch up with major overseas bio hubs such as the Boston Biotech Cluster.
Siga Ready For Next Phase, New Cash With Smallpox Drug Approval
Siga is entitled to a $41m “hold back” payment under its contract with the Biomedical Advanced Research and Development Authority and potentially a $50m payment related to the US FDA's extended shelf-life determination for stockpiled Tpoxx; company also picks up first priority review voucher awarded for a medical countermeasure, which it likely will monetize.
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Tecentriq Data Builds As IMpower132 In NSCLC Meets PFS Co-Primary Endpoint
As Roche keeps building its catalog of positive Tecentriq results, its Phase III IMpower132 study meets PFS endpoint in NSCLC, with OS data coming later.
Takeda/Ovid Broaden Pioneering CH24H Inhibitor To Rare Epilepsies
Takeda and partner Ovid are planning new trials in rare pediatric indications for their first-in-class epilepsy drug, including in the increasingly competitive area of Dravet syndrome.
Mersana's ADC Technology Faces A Setback With Partial Clinical Trial Hold
A patient death in a Phase I dose-escalation study of XMT-1522 in patients with HER2-expressing tumors rattled investors, but CEO Protopapas said it is not clear what the cause of death was in the very sick patient and that Mersana is working closely with the FDA.
Bone Therapeutics: Helping Bone Regenerate, And To Knit Together
Executive Interview: A raft of clinical trial results are expected in the second half of 2018 for Bone Therapeutics' regenerative cell therapy approach to hip osteonecrosis and delayed-union fractures.
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