Bio Pharma Dive
MAY 24, 2023
The agency will extend its review of Sarepta’s treatment by roughly one month as it weighs limiting an initial OK only to children with Duchenne aged 4 to 5 years old.
Pharmaceutical Technology
MAY 24, 2023
By Luisa Sterkel & Joana Loureiro , Tenthpin Consultants The promise and potential of cell and gene therapies (CGT) has emerged in the recent past and currently over 1.500 CGT are registered for clinical trials holding great hope for the treatment of challenging and uncurable diseases. The ability to modify or introduce genetic material in human cells in such a precise and patient-centered manner clearly constitutes a breakthrough in personalized medicine.
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Bio Pharma Dive
MAY 24, 2023
The drug, called Xacduro, will be made available later this year by Innoviva Specialty Therapeutics, a new company formed from antibiotic developers Entasis and La Jolla.
Pharmaceutical Technology
MAY 24, 2023
Forge Biologics has joined the public-private collaboration, the Bespoke Gene Therapy Consortium (BGTC), to expedite the development and manufacture of new AAV [adeno-associated virus] gene therapies to treat patients with rare diseases. The BGTC is part of the accelerating medicines partnership (AMP) programme and is managed by the Foundation for the National Institutes of Health (FNIH).
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There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.
Bio Pharma Dive
MAY 24, 2023
The biotech is giving up on early-stage gene therapy research as part of a restructuring meant to cut costs and redirect resources toward therapies most likely to succeed.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 24, 2023
An estimated 2.8 million people around the world have multiple sclerosis (MS), an autoimmune disease in which the immune system damages the brain and spinal cord. Symptoms include fatigue, vision disturbance, problems with mobility and balance, and cognitive dysfunction.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 24, 2023
With an intention to bring both the administrations of the food safety department and the drug control under one controller, the Government of Tamil Nadu has given the charge of director of drugs control administration (DCA) to the commissioner of food safety, R Lalvena, an IAS officer.
Pharmaceutical Technology
MAY 24, 2023
HBM’s wholly owned subsidiary Nona Biosciences has entered an agreement with OPKO Health’s ModeX Therapeutics for the discovery of antibodies. ModeX Therapeutics will gain access to the fully human Harbour Mice platforms of Nona Bioscience for integration into its MSTAR platform to expedite the monoclonal antibodies’ discovery. This is expected to significantly shorten the preclinical antibody therapeutics development process.
Fierce Pharma
MAY 24, 2023
Innoviva subsidiary Entasis scores FDA nod for bacterial pneumonia combo drug Xacduro kdunleavy Wed, 05/24/2023 - 09:46
Pharmaceutical Technology
MAY 24, 2023
Innoviva has snagged a win for its bacterial pneumonia drug Xacduro (durlobactam sodium + sulbactam) with a US Food and Drug Administration FDA approval for use in patients of ages 18 or older. The intravenous therapy has become the first pathogen-targeted therapy approved for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex (ABC).
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
XTalks
MAY 24, 2023
Leading health solutions company CVS Health recently disclosed that its clinical trial business will shut down just two years after its initiation in May 2021. The company will gradually wind down its CVS Health Clinical Trial Services unit with full exit by December 31, 2024. According to the company, it is an attempt to focus on its core businesses which include retail pharmacy, health insurance, prescription drug coverage and health care and wellness. “We continually evaluate our portfo
Pharmaceutical Technology
MAY 24, 2023
The US Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) have announced steps to push down prescription drug prices under Medicaid as part of a new proposal. The potential regulation, announced on 23 May, includes steps that states can carry out to manage their drug expenditure, particularly in the context of new high-cost treatments such as cell and gene therapies.
XTalks
MAY 24, 2023
Manuka honey, a natural product renowned for its antibacterial and potential health benefits, has been at the center of a prolonged legal dispute between Australia and New Zealand. The conflict involves the naming rights to “Manuka honey,” a product whose potential health benefits and significant price markup have made it a highly sought-after commodity in the international market.
Pharmaceutical Technology
MAY 24, 2023
Y-mAbs Therapeutics has received marketing authorisation for Danyelza (naxitamab-gqgk) 40mg/10mL injection from the Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária, to treat high-risk neuroblastoma. Danyelza is a recombinant humanised monoclonal antibody that acts on the ganglioside GD2 that is highly expressed in several neuroectoderm-derived tumours and sarcomas.
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XTalks
MAY 24, 2023
Eyecare giant Bausch + Lomb received its first prescription drug approval from the US Food and Drug Administration (FDA) for its dry eye disease med Miebo (perfluorohexyloctane ophthalmic solution). The eye drops are the first and only FDA-approved treatment that directly target tear evaporation at the ocular surface to treat the signs and symptoms of dry eye disease.
Pharmaceutical Technology
MAY 24, 2023
Inovio has received orphan drug designation for INO-3107 from the European Commission (EC) to treat recurrent respiratory papillomatosis (RRP). The investigational DNA medicine candidate INO-3107 has been designed for eliciting a targeted T cell response against HPV[human papillomavirus]-6 and HPV-11, the types of HPV that cause RRP and other related diseases.
Fierce Pharma
MAY 24, 2023
Biopharma staffers exhausted and susceptible to burnout, report says kdunleavy Wed, 05/24/2023 - 16:52
Pharmaceutical Technology
MAY 24, 2023
CohBar has entered into a definitive merger deal with Morphogenesis to advance a late-stage clinical immuno-oncology pipeline of therapies to overcome resistance to cancer immunotherapy. Expected to operate under the name TuHURA Biosciences, the combined company will focus on advancing two technologies of Morphogenesis that seek to overcome the major hurdles which limit existing immunotherapies’ effectiveness in treating cancer.
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
Drug Channels
MAY 24, 2023
In The Top Pharmacy Benefit Managers of 2022: Market Share and Trends for the Biggest Companies , I shared Drug Channels Institute's analysis showing that three pharmacy benefit managers (PBMs)—the Caremark business of CVS Health, the Express Scripts business of Cigna, and the OptumRx business of UnitedHealth Group—accounted for about 80% of total equivalent prescription claims in 2022.
Pharmaceutical Technology
MAY 24, 2023
The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Recombinant viral vect
Pharma Times
MAY 24, 2023
Vital data supports early intervention in order to treat chronic obstructive pulmonary disease
Pharmaceutical Technology
MAY 24, 2023
The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Tetrapeptide derivativ
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Fierce Pharma
MAY 24, 2023
After years of litigation, Gilead and Teva's HIV antitrust trial kicks off in California zbecker Wed, 05/24/2023 - 17:17
Pharmaceutical Technology
MAY 24, 2023
Rocket Pharmaceuticals has received Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its gene therapy RP-L301 to treat pyruvate kinase deficiency (PKD), The investigational lentiviral-based gene therapy comprises autologous (patient-derived) hematopoietic stem cells (HSCs) genetically modified with a lentiviral vector containing a functional copy of the PKLR [pyruvate kinase-encoding] gene.
Pharma Times
MAY 24, 2023
Celadon will sell a minimum of £3m worth of the high-THC product over the next three years
Pharmaceutical Technology
MAY 24, 2023
China’s National Medical Products Administration (NMPA) has accepted Shanghai Junshi Biosciences ’ supplemental new drug application (sNDA) for toripalimab in combination with chemotherapy to treat advanced triple-negative breast cancer (TNBC). The anti-PD-1 monoclonal antibody toripalimab will be used along with albumin-bound paclitaxel to treat PD-L1 positive (CPS ≥ [greater than or equal to] 1) untreated metastatic or recurrent metastatic TNBC.
Fierce Pharma
MAY 24, 2023
FDA clears Braeburn's long-acting Braxadi to treat opioid use disorder zbecker Wed, 05/24/2023 - 09:15
Pharmaceutical Technology
MAY 24, 2023
Earlier this month, Novo Nordisk revealed that they would be limiting starter doses of their obesity pharmacotherapy, Wegovy (semaglutide), in the US until September, in an effort to avoid running into supply shortages. It is an issue that the company faced in March 2022, which resulted in halted sales of Wegovy and a delay in launching in the EU. The demand for Wegovy currently outweighs supply capacity, as it is the first therapy to be approved in the obesity space that is administered on a we
pharmaphorum
MAY 24, 2023
A new ABPI president; a new take on health, productivity, and partnerships – ABPI Conference part two Mike.
BioSpace
MAY 24, 2023
Annexon Sets Sights on Phase III Geographic Atrophy Trial Despite Missing Mid-Stage Mark 5/25/2023
BioPharma Reporter
MAY 24, 2023
Cartherics, a biotechnology company developing immune cell therapies for the treatment of cancer, will be presenting at the upcoming 2023 BIO International Convention in Boston.
BioSpace
MAY 24, 2023
What People with Autism Wish Their Employers Knew 5/25/2023
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