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AstraZeneca Q2 Preview: Cancer Drug Trio To Keep Growing

Tagrisso, Lynparza and Imfinzi are enjoying stellar sales growth which is unlikely to slow down any time soon.

Sales & Earnings Cancer Companies

Biogen Growth Continues, But Analysts Worry About Near-Term R&D Prospects

The biotech’s MS franchise led by Tecfidera grew strongly, while SMA therapy Spinraza dipped slightly, but Biogen maintains optimistic outlook among growing competition.

Sales & Earnings Commercial Research and Development Strategies

Pimavanserin Fails In ENHANCE But Other CNS Uses Targeted

Acadia halts evaluation of pimavanserin as a schizophrenia adjunct but continues study of effect on negative symptoms and in other CNS conditions.

 

Clinical Trials Research & Development Companies
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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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A New Day Dawns For Avastin

The launch of Mvasi will be the first biosimilar version of Avastin in the US, a huge blockbuster for Roche approved for multiple cancer indications. Scrip looks at the development and commercial history of Avastin since its FDA approval in 2004. 

Biosimilars Launches Commercial

Myovant Plans Q4 Uterine Fibroid Drug Filing In A Showdown With AbbVie

A second Phase III trial testing relugolix met its primary endpoint, putting Myovant in a tight race with AbbVie to bring the first drug to market for women with uterine fibroids.

Clinical Trials Business Strategies Gynecology & Urology

Vadadustat Emerges As Japan HIF-PHI Leader With First Filing Globally

Competition intensifies in novel anemia therapy space in Japan with first filing globally for Akebia/Mitsubishi Tanabe’s contender vadadustat, which could see its first launch worldwide in the country.

Japan Commercial

Kleo Brings Small-Molecule Approach To IO With Three Technological Applications

Emerging Company Profile: Using IP licensed from Yale, Kleo is betting it can complement or replace existing immuno-oncology drugs, specifically Darzalex. In partnership with PeptiDream, it just unveiled its first candidate for clinical development.

ImmunoOncology Business Strategies

Changes Encourage Celltrion And Nan Fung To Bet On China Biosimilars Opportunity

Despite increasing competition, Celltrion has leapt into China's growing biosimilar market through a joint venture with Nan Fung, and another draw could lie in the biologics contract manufacturing potential in the country’s developing Greater Bay Area.

China Biosimilars

Novartis Ceritinib India Case: Court Rebuke Amid Wait For Patent Decision

An Indian court has frowned upon Novartis and opponent Natco for seemingly delaying proceedings before the Controller General of Patents in a case concerning the Swiss firm’s anticancer ceritinib. The patent office wasn’t spared either, with the court asking the Controller to ensure that once orders are reserved, a time period is prescribed for delivering the decision.

India Legal Issues

Lyrica Generics Launch, But Pfizer Has Been Bracing For The Hit

The first generic versions of Pfizer's blockbuster pain medicine pregabalin have launched in the US. Pfizer has guided investors the company will return to growth in 2020 after cycling through the loss.

Generic Drugs Launches

Product Sales, Pipeline & Biosimilar Timelines Key Themes For Roche 2Q

Investors during Roche’s second-quarter update on Thursday will look for updates on coming biosimilar competition, promising pipeline assets, and the delayed Spark Therapeutics acquisition.

Commercial Companies

Policy & Regulation Explore this Topic

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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

Research & Development Explore this Topic

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Blonanserin On Course As First Atypical For Adolescent Schizophrenia In Japan

Dainippon drug likely to become first atypical to be approved for adolescent schizophrenia in Japan following planned filing based on positive new Phase III results.

Japan Clinical Trials Business Strategies

Pipeline Watch: Phase III Trials Announced For HIV Vaccine, RecAP And Tucatinib

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

UK's AMRC Licenses Shionogi Superbug Therapy

As it waits for a US FDA decision on its antibiotic cefiderocol, the Japanese company has handed over the rights to a Pseudomonas aeruginosa therapy that will go into the clinic next year.

Infectious Diseases Companies

Pyxis Oncology: New Routes To Immuno-Oncology Therapies

Bayer’s VC LEAPS program invests in a second new biotech this month through its participation in the series A funding round for new immuno-oncology biotech Pyxis Oncology.

 

Financing ImmunoOncology
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