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HIV Market Snapshot: Gilead's Biktarvy Set To Soar, But ViiV May Win In The End
Gilead's Biktarvy (B/F/TAF) single tablet is poised to become a huge success, surpassing competitors in the HIV market by far, but the GlaxoSmithKline-backed ViiV Healthcare looks better positioned in the long run.
AstraZeneca Bolstering India Play With $90m Investment Plan
AstraZeneca expects to invest $90m over five years to shore up its footprint in India – a market where the Anglo-Swedish major has introduced a string of new products but has also had a fair share of challenges.
In The Hot Seat: Bristol Defends IO Position Amid Sliding Stock And Forecasts
Bristol's stock price dipped after the AACR meeting, where pivotal lung cancer data for Opdivo/Yervoy disappointed relative to Merck's Keytruda/chemo combo, but Bristol still has many immuno-oncology irons in the fire in other indications and expressed confidence in its strategy.
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Meeting Growth Challenges Roundtable Panel Part 3: Pursuing Growth Without Overreaching
Three decades ago when biotech was in its infancy many of the pioneers had ambitions to create fully integrated pharmaceutical companies (FIPCOs). Picking low hanging fruit – recombinant versions of therapeutically relevant human proteins, such as insulin, human growth hormone, erythropoietin and tissue plasminogen activator – a number of the first movers prospered but many withered on the vine. The FIPCO model fell out of fashion and subsequent start-ups pursued strategies that took assets to proof of concept before licensing to established commercial organizations. The advent of personalized medicines and initiatives to incentivize development of therapeutics to treat orphan diseases has underpinned a renaissance of the FIPCO model. However, challenges still exist.
Commercial Explore this Topic
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IOnctura CEO On Pipeline Strategy And Funding Goals
IOnctura’s CEO Catherine Pickering outlines the company’s business model and its approach to cancer R&D targeting the tumor microenvironment.
Ultragenyx Gets Second Drug Approval; Crysvita With Kyowa Hakko Kirin
Ultragenyx already has a sales team in place to market its second commercial drug Crysvita (burosumab) – partnered with Kyowa Hakko Kirin – following its April 17 FDA approval for the treatment of pediatric and adult patients with x-linked hypophosphatemia (XLH).
Novo Seeds: Investing In Biopharma Growth
Stephan Christgau, a senior partner at Novo Seeds, talks about the firm’s approach to early-stage funding in biotech and how this financing arm aligns with Novo’s broader strategy.
TVM Raises White Flag On Biovertis & Morphochem
Denoive acquires from TVM Capital both Biovertis and Morphochem, plus a Phase II ready antibiotic asset, for an initial 4% stake worth €900,000. Since their formation, Biovertis and Morphochem have had more than $96m invested in them.
Struggling Fibrocell To Consider All Strategic Directions Going Forward
Rigel Readies Tavalisse For Late-May Launch After FDA Approval
Rigel has its first US FDA approval for Tavalisse (fostamatinib) and plans to launch the drug for adults with immune thrombocytopenia (ITP) in late May, after working on the drug's development for more than a decade across multiple indications.
Pfizer Seeks To Block Infringement Of Sutent Patent In India
At J&J, Oncology Closes In On Immunology As The Leading Pharma Franchise
Global oncology sales grew 45% to $2.31bn in the first quarter, powered by strong growth of Darzalex, Imbruvica and Zytiga, narrowing the gap with J&J's top-selling immunology franchise.
Policy & Regulation Explore this Topic
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Modus CEO Says Rare Disease Priority Review Voucher To Be Key Catalyst
The US FDA gives Sweden's privately held Modus Therapeutics rare pediatric disease designation for sickle cell disease.
China Vs Cancer: An Infographic Snapshot
Cancer cases are rising in China, with larger increases for certain types including thyroid and pancreatic. To combat the rising tide, the government will implement zero tariffs on imported anticancer drugs from May.
India Leads Global 65% Surge In Antibiotics Use
Human antibiotic consumption globally jumped dramatically between 2000 and 2015, with India posting the biggest rise, reports a new US study, which calls for a radical policy rethink to prevent antimicrobial drug resistance soaring.
FDA Reversal Puts Alkermes Depression Drug Back On Track For January Approval
Reversing an earlier decision, FDA accepted Alkermes' new drug application (NDA) for ALKS 5461 for review, with a target action date of Jan. 31. But the company could still face a tough FDA review.
Research & Development Explore this Topic
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With Back-To-Back FDA Holds, Solid Hopes To Regain Footing For Duchenne Candidate
Experts Challenge GSK Triple Inhaled COPD Therapy Claims
While GSK and collaborators publish findings from the IMPACT trial comparing once-daily single-inhaler triple versus dual therapy in patients with COPD in NEJM, two clinicians in an accompanying editorial argue that the trial falls short of providing robust evidence for switching strategy.
BenevolentAI Scoops $115M For AI Drug Development
At a pre-money valuation of $2bn, BenevolentAI raises $115m to develop artificial intelligence approach that already can cut early drug development timeline by four years.
How Will Novel Agents Impact The HIV Market?
ViiV and Merck are looking to novel mechanisms of action as an opportunity to make up ground on HIV leader Gilead, which has de-emphasized early virology research.
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