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Novartis Q2 Preview: All Eyes On New Launches

The Basel-headquartered company has launched three high-profile drugs in the past couple of months. Analysts are waiting to see what initial impact these potential future growth drivers are having.

Sales & Earnings Strategy Neurology

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 Policy

Finance Watch: Among Multiple Mega-Rounds, Revolution Raises $100m For RAS Programs

Private Company Edition: Revolution Medicines follows its Sanofi partnership and Warp Drive Bio buyout with a series C venture capital round to fund its RAS pathway inhibitors in cancer. The financing came during a boom in $100m-plus VC financings, including BioNTech's $325m series B.

Financing Business Strategies Innovation
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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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Pharma's Big Defeat: US Rebate Proposal Hits The End Of The Road

White House will not move forward with a rebate proposal the drug industry supported as a way to lower patient drug spending.

Regulation Reimbursement Pricing Debate

GSK Divests China Suzhou Site, Antiviral Rights To Fosun

GSK becomes latest pharma multinational to offload assets in China as competition and pricing pressure continue to mount.

China Commercial Deals

GSK's Zejula Poised To Take On Lynparza In First-Line Ovarian Cancer

The Phase III PRIMA study in first-line ovarian cancer was positive for progression-free survival in patients regardless of their biomarker status, GSK reported.

Cancer Clinical Trials

Bayer-Natco Stivarga Infringement Case Simmers In India

Bayer is battling Natco in another high-profile infringement suit in India, this time pertaining to its anticancer Stivarga (regorafenib). The case has many legs and is to be re-heard by a single judge on the orders of a division bench.

India Legal Issues

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."

Deals Companies

$5bn Galapagos Deal Won’t Be Last For Gilead, Says O’Day

Handing over $5bn to Galapagos for access to several shots on the inflammation/fibrosis goal, Gilead Sciences CEO Daniel O’Day is still on the prowl for more.

Deals Companies

Shaw Leaves Lilly To Helm Gilead’s Kite

After heading up Lilly Bio-Medicines for two-and-a-half years, Shaw will take over Gilead’s gene therapy subsidiary. At Lilly, she oversaw the approvals of Olumiant and Emgality and helped grow Taltz.

Business Strategies Leadership

Redx Cashes In Cancer Program With Jazz Pact

Shares in the UK biotech tripled to a 52-week high after it announced the sale of its pan-RAF inhibitor program to Jazz that could eventually be worth around $200m.

M & A Cancer

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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 Cost Effectiveness

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

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

In A Win For Amgen, Court Blocks Sanofi/Regeneron's Praluent Sales In Germany

A court in Dusseldorf ruled that Praluent infringes a patent for Amgen's better-selling PCSK9 inhibitor Repatha, saying that Sanofi and Regeneron must stop selling their biologic in Germany. It's unclear whether there will be any readthrough to ongoing patent disputes in other countries.

Intellectual Property Legal Issues

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Novartis/Amgen End CNP520 Studies, Leaving Eisai/Biogen With Last BACE Inhibitor In The Clinic

An interim look at two Phase II/III trials showed the drug worsened cognition in people at high risk of developing Alzheimer's disease. This is the 16th failure of a BACE-targeting therapy.

Clinical Trials Neurology Research and Development Strategies

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."

Deals Companies

Pipeline Watch: Top-Line Phase III Results With Emicizumab, Lumateperone And Dabigatran

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

 

Pipeline Watch Approvals
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