Sun.Oct 08, 2023

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Malaria Could Be Eliminated by 2040: New Vaccine Offers Hope

AuroBlog - Aurous Healthcare Clinical Trials blog

The World Health Organization has approved a new vaccine that scientists argue will be a game-changer in the fight against malaria, which kills half a million people in Africa every year.

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Bristol Myers to buy KRAS cancer drug developer Mirati for $4.8B

Bio Pharma Dive

Mirati shareholders could also receive another $1 billion should an experimental cancer drug the biotech is developing make it to U.S. regulators’ desks.

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First RNA Editing Therapy Nears Clinic as Excitement Mounts

BioSpace

Its reversible nature offers the potential for RNA editing to go beyond rare diseases, eliciting excitement and buy-in from large pharmas like GSK and Eli Lilly.

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Bristol Myers Squibb buys Mirati for up to $5.8B as I-O giant branches out into targeted therapy for cancer

Fierce Pharma

After years serving as a rumored target of Big Pharma M&A, Mirati Therapeutics has finally made its sale a reality. | After years serving as a rumored target of Big Pharma M&A, Mirati Therapeutics has finally made its sale a reality. The buyer, Bristol Myers Squibb, will pay up to $5.8 billion for the KRAS drugmaker.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Novartis Wins FDA Approval for Intravenous Cosentyx Formulation

BioSpace

The Swiss pharma continues its winning streak with the FDA’s approval of the intravenous formulation of Cosentyx for ankylosing spondylitis, axial spondyloarthritis and psoriatic arthritis.

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CONTINUED AGAIN: DEA Announces A Second Extension of its “Temporary Rule” Addressing Telemedicine Flexibilities After the End of the COVID-19 Pandemic Emergency

FDA Law Blog

By Karla L. Palmer — On Friday, October 6, 2023, DEA announced a second extension of telemedicine flexibilities concerning the prescribing of controlled substances, which were originally set to expire after the end of the COVID-19 pandemic emergency. As a reminder, back in February 2023, HPM blogged about DEA’s two proposed rules for prescribing (1) controlled substances generally and (2) for buprenorphine use in opioid treatment.

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New tentative approval for Mylan Gmbh drug trastuzumab-dkst

Drug Patent Watch

For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or visit www.DrugPatentWatch.com The post New tentative approval for Mylan Gmbh drug trastuzumab-dkst appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59
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FDA Blocks Alnylam’s Bid to Expand Onpattro Label

BioSpace

Despite winning the backing of an FDA advisory committee, the regulator in a Complete Response Letter declined Alnylam’s bid to expand Onpattro’s label to cardiomyopathy in ATTR amyloidosis.

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Health Care Staff Turnover and Quality of Care at Nursing Homes

JAMA Internal Medicine

This cross-sectional study examines whether greater periods of nursing staff turnover are associated with quality of care in US nursing homes.

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6 Drugs Approved Despite Failed Trials or Minimal Data

BioSpace

Recent FDA approvals of novel drugs based on less-than-stellar clinical evidence point to a trend toward regulatory flexibility—particularly in indications with very high unmet need.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Which pharmaceutical companies have the most drug patents in Ecuador?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Ecuador. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is… The post Which pharmaceutical companies have the most drug patents in Ecuador? appeared first on DrugPatentWatch - Make Better Decisions.

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