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AbbVie's Alzheimer's Efforts Voyage Into AAV-Targeted Tau Antibodies

Collaboration between Voyager and AbbVie will attempt to produce a single-administration gene therapy targeting tau protein, using adeno-associated vector technology to pass the blood-brain barrier.
Research & Development Deals Neurology

Aimmune Accelerates Commercial Planning For Peanut Allergy Drug

Even better than expected efficacy and safety in the Phase III PALISADE trial puts Aimmune on track to file its BLA for peanut protein capsule AR101 by the end of 2018.

Clinical Trials Immune Disorders Pediatrics

Compliance Continues To Curtail Effective Asthma Treatment

The top two high-priority challenges to address in asthma treatment for respondents to a large survey by Datamonitor Healthcare of pulmonologists and primary care physicians in the US, Japan and Europe were improving compliance and developing effective, easy-to-use inhalers.

Respiratory Compliance Cost Effectiveness

Exploring Sanofi's Revamped IO Pipeline

In an exclusive interview, Sanofi's head of oncology development Joanne Lager explains how the French big pharma could make a comeback in cancer this year and highlights its immunotherapy combination opportunities.

Business Strategies ImmunoOncology Research and Development Strategies
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Osteoarthritis Stem Cell Therapy Could Be On Sale In India By 2020

A novel Indian stem cell injection treatment intended to slow down joint damage caused by osteoarthritis and potentially avert replacement surgery will undergo domestic Phase III trials this year and could be on sale in the country by 2020 under a licensing deal between Alkem Laboratories and biotech firm Stempeutics.

Commercial Deals India

Strides' Net Profit Dives But Regulated Markets Seen Delivering Growth

Strides Shasun has reported third-quarter net profit plunged by 57% but the Indian firm says performance will improve in coming quarters thanks to its regulated market focus, and analysts agree earnings look set to rise.
Commercial Companies Sales & Earnings

Momentum At Indian Innovation Start-Ups: Will Pharma Take Notice?

Several Indian startups - many with overseas links - appear to be taking a shot at developing, among others, novel treatments targeting multi-drug resistant infections, biobetters and personalized cell based therapy. Funding, though, hasn’t been easy, according to one biopharma advisory firm.

Commercial Companies

Can Sanofi’s Toujeo Prickle Tresiba In India?

Sanofi has launched its next generation basal insulin, Toujeo, on the Indian market at a significantly reduced per unit price point versus Novo Nordisk’s Tresiba (insulin degludec), setting the stage for an interesting market expansion battle.

India Pricing Strategies

Deal Watch: Roche Goes All-In On Real-World Data With Flatiron Acquisition

Already a significant investor in the health care technology firm, buyout will give Roche access to substantial real-world cancer development data. Astellas acquires stem cell-focused Universal Cells.

Deals Business Strategies

Roche To Build RWE Cancer Data Extraction Role With Flatiron Buy

Acquisition reflects that regulatory-grade real-world evidence will play increasing role in drug discovery, development, commercialization and reimbursement.

Business Strategies Commercial

Arix And China's Fosun Ink A Strategic Partnership

A new strategic partnership has been forged between Arix Bioscience and China's Fosun International to develop new business opportunities in China.

Deals StartUps and SMEs

Novartis Sale Of US Oral Generics Unit Seems Unlikely

The Swiss giant's Sandoz division is exploring options for its underperforming US oral generics unit but reports that it may be considering a sale of the latter go against Novartis' previous comments and observers are struggling to see the rationale behind such a move.

Generic Drugs M & A

Policy & Regulation Explore this Topic

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AstraZeneca's Imfinzi Scores First Early Lung Cancer Approval

Unlike other indications PD-1/L1 inhibitors are shooting for, Stage III non-small cell lung cancer is an untapped market and AstraZeneca will have the space to itself for a while.
ImmunoOncology Cancer Approvals

FDA Deputy On CRLs: 'It's Not Our Property To Release'

US FDA Principal Deputy Commissioner Rachel Sherman said during the BIO CEO & Investor conference that while investors and others would like to see complete response letters, the agency's hands are bound when it comes to their full release. Sherman also commented on FDA's focus for right-to-try legislation.

FDA Complete Response Letters

A First For Prostate Cancer: Janssen's Erleada Approved For Non-Metastatic Patients

J&J subsidiary Janssen's Erleada (apalutamide) is the first therapy approved for non-metastatic castration-resistant prostate cancer (nmCRPC). The US FDA decision came about two months early, but the drug – priced at $10,920 per month, or $131,040 annually – may soon face competition.
Approvals Cancer

Bayer In FDA's Bad Books Over Facility Failures

Not for the first time this decade, the German major has been warned by the US FDA about its manufacturing processes and sorting out the problems could affect supplies of some big-selling  products such as the blood pressure treatment Adalat and the erectile dysfunction drug Levitra.

Manufacturing FDA

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Lilly Halts Hanmi BTK Inhibitor Trial For RA, Mulls Other Indications

Hanmi Pharmaceutical shares fell sharply on the news Lilly has halted Phase II trials of the South  Korean firm’s BTK inhibitor for rheumatoid arthritis. But Hanmi says its license contract remains intact and that the two firms are discussing the potential development of the molecule for other indications.

Research & Development South Korea US States

Heart Failure Pipeline Review: Amgen's Omecamtiv And Merck's Vericiguat Step Up To Plate

In addition to small molecules, stem cell therapies promise to help rejuvenate the chronic heart failure pipeline, but high prices and invasive procedures may limit their use to end-stage patients, and skepticism about efficacy persists.

Cardiovascular Research & Development

Pipeline Watch: Phase III Progress With Avelumab, Ixekizumab And Eravacycline

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

Celgene's IBD Franchise Boosted by Otezla Ulcerative Colitis Success

The big-selling psoriasis drug has achieved healthy clinical remission rates in a Phase II trial for ulcerative colitis, and Celgene believes Otezla and another potential blockbuster, ozanimod, will help it build a significant presence in inflammatory bowel disease.

Gastrointestinal Clinical Trials
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