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Ultragenyx Buys GeneTx to Take Angelman ASO the Distance - Updated

Biospace news - Wed, 07/20/2022 - 02:00
The buyout comes on the heels of promising Phase I/II results from GTX-102, an antisense oligonucleotide candidate being developed to treat Angelman syndrome.

Pfizer and BioNTech complete submission to European Medicines Agency for Omicron BA.1 adapted bivalent vaccine candidate

World Pharma News - Tue, 07/19/2022 - 12:00
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the European Medicines Agency (EMA) for an Omicron-adapted bivalent COVID-19 vaccine candidate, based on the BA.1 sub-lineage, for individuals 12 years of age and older. This application follows guidance from the EMA and International Coalition of Medicines Regulatory Authorities (ICMRA) to work towards introducing an Omicron-adapted bivalent vaccine candidate to address the continued evolution of SARS-CoV-2.

Vaccine-induced immune response to omicron wanes substantially over time

World Pharma News - Tue, 07/19/2022 - 10:00
Although COVID-19 booster vaccinations in adults elicit high levels of neutralizing antibodies against the Omicron variant of SARS-CoV-2, antibody levels decrease substantially within 3 months, according to new clinical trial data. The findings, published today in Cell Reports Medicine, are from a study sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The trial was led by NIAID's Infectious Diseases Clinical Research Consortium.

Sanofi, Merck Shut Down Alport Syndrome, Colorectal Cancer Trials

Biospace news - Tue, 07/19/2022 - 02:00
Sanofi has terminated a development agreement with Regulus in Alport syndrome, while Merck reaches the point of futility in a Phase III colorectal cancer trial.

Genetown's Growing Pains: Eisai Shutters H3 Bio, Biogen Job Cuts have Begun

Biospace news - Tue, 07/19/2022 - 02:00
The Bay State, home to the busy bio-hub Genetown, is experiencing some growing pains. Companies like Biogen and Eisai (H3 Biomedicine) are reducing their headcount.

FDA Approves First At-Home Repigmentation Therapy for Nonsegmental Vitiligo

Biospace news - Tue, 07/19/2022 - 02:00
The FDA has approved Incyte's Opzelura as the first and only at-home therapy for repigmentation in nonsegmental vitiligo.

Prescription Stimulants for ADHD: Separating Fact from Fiction

Biospace news - Tue, 07/19/2022 - 02:00
There are myriad misconceptions about prescription stimulants for ADHD. But buried within the array of opinions, as with many hot-button topics, are small nuggets of truth.

COVID-19 Update: BA.4 and BA.5 Dominate, Long COVID Effects Continue, CDC Considers Novavax

Biospace news - Tue, 07/19/2022 - 02:00
As the BA.4/BA.5 Omicron subvariants spread, researchers continue to develop COVID-19 therapies and approaches for preventing or treating the disease. For that and more, continue reading.

Innovent & Eli Lilly's Type 2 Diabetes Drug Lowers HbA1c, Scores Early Win

Biospace news - Tue, 07/19/2022 - 02:00
Innovent Biologics' Phase II trial of mazdutide, a potential treatment for type 2 diabetes, showed the drug met its primary endpoint by successfully reducing HbA1c levels.

Cancer Researchers Find Clues in Blood Samples, Paralogs, Fungus and the Microbiome

Biospace news - Tue, 07/19/2022 - 02:00
Cancer research facilities are leading the way with methods that will lead to better detection of cancer metastasis, better understanding of cancer cell physiology and greater patient response.

50 Powerful Keywords For Your Resume to Indicate You’re a Leader

Biospace news - Tue, 07/19/2022 - 02:00
Consider limiting the use of “manage” on your resume, opting instead for more powerful keywords for your resume that can better indicate you're a leader.

Bayer to sell men's health product Nebido™ to Grünenthal

World Pharma News - Mon, 07/18/2022 - 10:00
Bayer and Grünenthal have entered into a definitive agreement regarding the sale of Bayer's men's health product Nebido™ (testosterone undecanoate), for a purchase price totaling up to 500 million Euro.

Nebido for the treatment of male hypogonadism (testosterone deficiency) is available in over 80 countries since 2004. In 2021, the product contributed sales of 117 million Euro to Bayer's overall sales of more than 44 billion Euro.

Vaccine protection against COVID-19 short-lived, booster shots important

World Pharma News - Fri, 07/15/2022 - 10:00
Since COVID-19 vaccines first became available to protect against infection and severe illness, there has been much uncertainty about how long the protection lasts, and when it might be necessary for individuals to get an additional booster shot.

Now, a team of scientists led by faculty at the Yale School of Public Health and the University of North Carolina at Charlotte has an answer: strong protection following vaccination is short-lived.

Omega Gets FDA Nod to Start First-Ever Epigenomic Controller Trial

Biospace news - Fri, 07/15/2022 - 02:00
Omega Therapeutics announced Thursday that the Investigational New Drug (IND) application for its hepatocellular carcinoma (HCC) candidate OTX-2002 has been granted by the FDA.

MIT’s Burst-Release Microparticles Could Lead to Fewer Boosters

Biospace news - Fri, 07/15/2022 - 02:00
​​​​​​​Once proven clinically safe and effective, MIT's technology could pave the way toward “self-boosting” vaccines and eliminate the need for multiple shots.

Are Things Breaking Bone’s Way? Improved Statistical Analysis Could Speed Development

Biospace news - Fri, 07/15/2022 - 02:00
As a result of this new data, the company “has improved the statistical analysis of the ALLOB Phase IIb study." The changes should speed up the overall recruitment and study.

Will 90 be the New 40? Genomics and Precision Medicine Equal Longer Health Span

Biospace news - Fri, 07/15/2022 - 02:00
Recent advances in precision medicine and genomics have launched an explosion in immunotherapies that are resulting in real cures and earlier diagnoses - and more healthy years for individuals.

Roche Wraps Week with a Bang, Touting Long-Term Breast Cancer, AMD Data

Biospace news - Fri, 07/15/2022 - 02:00
Roche had a good week, sharing positive data from Genentech's study on Vabysmo for age-related macular degeneration and its breast cancer combination therapy, Perjeta.

Alzheimer's Research Moves Ahead with Whole Blood Exchange, Tau Revelations

Biospace news - Fri, 07/15/2022 - 02:00
Researchers point out that antibodies against amyloid are still considered an essential approach to treating Alzheimer’s, but the leading risk factor for sporadic AD is aging.

BioSpace Movers & Shakers: Astria, Apertura, CytoDyn, IN8bio & More Make Big Moves

Biospace news - Fri, 07/15/2022 - 02:00
New leaders and top executive roles were selected to guide biopharma and life science companies from Apertura Gene Therapy to CytoDyn, Vaccentis AG, Suvoda LLC, IN8bio and more.