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GSK Q2 Preview: Focus On PARP And HIV Pill

Analysts are waiting to see how the drugs giant intends to drive growth for new products, with a particular interest in the prospects for the PARP inhibitor Zejula and the single-pill, two-drug HIV therapy Dovato.

Sales & Earnings Cancer Clinical Trials

Systems Biology In CNS: Mixed Results For IRLAB's Dyskinesia Candidate

A novel systems biology/network pharmacology approach to drug discovery in Parkinson’s disease is encouraging despite puzzling divergence in efficacy measures.

 

Neurology Clinical Trials Research & Development

Elios' Phase IIb Melanoma Data Are Promising, But Present Tricky Issues For Phase III Vaccine Study

The biotech’s personalized vaccine shows it can reduce the risk of melanoma recurrence by 50% in the per-treatment population, but Phase III will need to demonstrate a similar benefit in an intent-to-treat population.

Clinical Trials Research & Development Vaccines
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PRECISION MEDICINE RESEARCH: How Advanced Data Analytics Support The Journey From Clinic to Bedside

Precision medicine offers huge promise to patients and health systems. It can also substantially increase the efficiency of drug development by enabling more focused, data-rich clinical trials.

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Embedding Time-Critical Scheduling in Drug Production

Manufacturing is the engine room of the pharmaceutical industry. Ultimately, a medicine has little value if it does not reach patients on schedule, in the required quantity and quality. Download this whitepaper which discusses time-critical scheduling in drug production.

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Biogen Q2 Preview: Can It Change The Narrative After Q1 Strength Was Overshadowed?

Despite 11% sales growth during the first quarter, Biogen faces pessimism about continuing to pursue the amyloid hypothesis in Alzheimer’s and competitive threats to Spinraza and Tecfidera. ALS and biosimilars may offer upside.

Sales & Earnings Business Strategies Commercial

Boehringer Ingelheim To Boost Cancer Immunology Portfolio with Novel Cancer Vaccines

By buying AMAL, Boehringer Ingelheim plans to develop new therapies by combining assets from its cancer immunology portfolio with the biotech’s KISIMA immunization platform, the German pharma’s head of cancer immunology business development tells Scrip.

Deals Companies Cancer

Interview: AbiVax Equipped To Enter Anti-Inflammatory Market

The French biotech's CEO tells Scrip the firm now has the time and resources to sign up a big pharma partner for its ulcerative colitis, RA and Crohn’s candidate.

Financing Inflammation

Astellas Adds To Regenerative Medicine Portfolio In Hearing Loss Deal With Frequency

Astellas adds a large-market drug candidate to its regenerative medicine portfolio, while Frequency Therapeutics almost doubles its fundraising to date. It traded ex-US rights to hearing loss candidate FX-322 for $80m up front and up to $545m in milestone fees plus royalties.

Deals Regenerative Medicine

Loss And Gain: Trade War Halves China Biotech VC Funding To US, But Asian Countries May Benefit

Chinese venture funding to the US biotech sector has fallen by nearly 60% in the latest sign of cooling in the previously booming bilateral life sciences investment sector.

China Financing

Cipla Docks Into China, Manufacturing Plans In Tow

More Indian companies are headed to China, with Cipla the latest to seal a joint venture there, though the firm has previous links with the country. Respiratory products will lead Cipla’s line-up in China, a market seen as a crucial cog in the firm’s future road map.

China Commercial

Deal Watch: Genentech Inks New Collaborations With Skyhawk, Convelo

Skyhawk continues its recent spate of deal-making, using its SkyStar platform in a deal with Genentech, which also is looking into neurology with Convelo. AbbVie buys STING specialist Mavupharma, while Recordati pays Novartis $390m for Cushing’s products.

Deals Business Strategies

J&J US Pharma Sales Under Pressure From Pricing And Generics

A 6% negative pricing impact in the US and generic Zytiga were headwinds for Johnson & Johnson's pharmaceutical business in the second quarter.

Sales & Earnings Launches

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AstraZeneca’s Farxiga Fails To Get FDA OK As Insulin Supplement In Type 1 Diabetes

The UK pharma said the FDA had issued a complete response letter, declining its application for using Farxiga in the new T1D indication. Analysts suspect worries over diabetic ketoacidosis risk lie behind the rejection.

Approvals Companies Metabolic Disorders

Suspicions Raised Over Medytox’s Botulinum Toxin Amid Ongoing Court Battle

Shares of Korea's Medytox fell on suspicions that it supplied botulinum toxin to local hospitals before the product's approval in 2006. The concerns add to other manufacturing issues that have been denied by the company, which pointed to a rival as the possible source amid an ongoing legal battle over the strain used in the product.

South Korea Aesthetics

Real-World Reluctance? Despite Guidance, Drug Developers Wary Of RWE-Based Trials

Biopharma companies are reluctant to rely on real-world evidence trials, but while uncertainty remains about how these novel studies will be accepted, US and other regulators are encouraging drug developers to take a chance – and some have taken on the challenge.

Clinical Trials Research and Development Strategies

Mehta Analysis: What Do Facebook Libra And Democrats At Presidential Debates Have In Common?

Viren Mehta of Mehta Partners LLC mulls the potential of blockchain, the rapidly evolving IT resource that secures every step in a business action.

Healthcare Systems Innovation

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Key Catalyst In August For Mologen As IMPALA Phase III Colorectal Cancer Reports

Mologen CEO says next month’s pivotal trial topline readout on its lead asset lefitolimod will be important for the German-based immunotherapy pioneer of DNA-based TLR9 agonists.

Clinical Trials Companies Research & Development

Positive Results Move Anemia Contender Enarodustat Towards First Filing

Japanese firms unveil pivotal top-line results that pave way for first filing of novel anemia therapy within new class of agents, but competition is high and timings remain unclear.

Japan Clinical Trials

Capricor’s Interim Data Could Offer Hope For Older DMD Patients

Although only interim data from six treated patients, Capricor’s Phase II DMD study shows improvements in upper limb performance, grip strength and respiration. Cardiac performance shows positive trend, but not yet statistical significance.

Clinical Trials Rare Diseases

Galapagos CEO Interview: Independence Allows Us To Keep Innovating

Having signed a major alliance expansion with Gilead, Onno van Stolpe tells Scrip that any takeover talk about Galapagos would be "unacceptable and unwanted."

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