Novartis buys rare disease gene therapy from Avrobio
Bio Pharma Dive
MAY 22, 2023
The pharma will pay nearly $90 million to acquire Avrobio’s treatment for cystinosis, an inherited condition caused by the toxic buildup of an amino acid.
Mon.May 22, 2023
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Readmission on the Horizon: How EU funding can boost British biotech
Pharmaceutical Technology
MAY 22, 2023
Amid high inflation , the latest banking crisis , and the continued repercussions of Brexit, the talent pool at British universities remains a major draw for British biotech. Now, the country’s possible participation in the EU’s Horizon Europe scheme would serve to boost the industry during a challenging time. Recent negotiations between the UK and the EU have opened the country’s prospects to re-joining the Horizon Europe program, which has been welcomed by biotechs and institutions alike.
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Ironwood to buy rare disease drugmaker in billion-dollar deal
Bio Pharma Dive
MAY 22, 2023
The acquisition would give Ironwood a drug in late-stage testing for a condition known as short bowel syndrome, further building out the company’s gastrointestinal-focused research.
CureVac gets an early date in Covid-19 vaccine patent case with Pfizer/BioNTech
Pharmaceutical Technology
MAY 22, 2023
The ongoing patent litigation between CureVac and Pfizer /BioNTech will move to a court in Virginia following a request from Curevac, potentially bringing forward the trial date to sometime in 2024. The Covid-19 pandemic saw a proliferation in novel vaccine technologies being produced rapidly. With the emergence of vaccines came accusations of technology encroachment amongst biotech companies.
Running Decentralized Trials at Scale: Planning for Success
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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.
Racing to the finish line: help for reducing risks, ensuring security and driving faster speed-to-market
Bio Pharma Dive
MAY 22, 2023
When pharma manufacturers are racing to bring a new product to market, catastrophic printing errors and mislabeled materials can have a significant impact on timelines and budgets.
China’s NMPA accepts IND for SinoMab BioScience’s SM17 to treat asthma
Pharmaceutical Technology
MAY 22, 2023
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma. SM17 is a humanised IgG4-k monoclonal antibody that targets IL-17RB to treat asthma, idiopathic pulmonary fibrosis (IPF), atopic dermatitis (AD) and other immunological disorders.
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EMA validates Sobi’s marketing authorisation application for efanesoctocog alfa
Pharmaceutical Technology
MAY 22, 2023
The European Medicines Agency (EMA) has accepted and verified Sobi’s marketing authorisation application for a new factor VIII (FVIII), efanesoctocog alfa, to treat haemophilia A patients of all ages. The application is supported by results from the Phase III XTEND-1 trial in adults and adolescents and backed by the XTEND-Kids paediatric trial in patients aged under 12 years.
FDA approves Krystal gene therapy for rare wound disorder
Bio Pharma Dive
MAY 22, 2023
Cleared to treat dystrophic epidermolysis bullosa, Vyjuvek is the sixth gene therapy for an inherited disease to gain clearance in the U.S.
Intercept suffers setback with negative AdCom decision for NASH therapy
Pharmaceutical Technology
MAY 22, 2023
Intercept Pharmaceuticals faced a setback after a US Food and Drug Administration’s (FDA) Advisory Committee (AdCom) meeting on the prospective use of its drug Ocaliva in pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH) did not go in its favour. Twelve of the 16 AdCom members gave out a negative vote on whether the benefits of 25mg of Ocaliva outweigh the risks in NASH patients with Stage 2 or Stage 3 fibrosis based on available data.
DoP floats tender to appoint consultant for valuation of BPCL
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 22, 2023
The Department of Pharmaceuticals (DoP) is initiating processes for valuation of the assets of Bengal Chemicals & Pharmaceuticals Ltd (BCPL) – a public sector undertaking which has shown resilience to overcome its financial troubles to turn around to profit – as part of the Central government’s divestment plans.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
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.
Thermo Fisher Scientific opens sterile drug facility in Singapore
Pharmaceutical Technology
MAY 22, 2023
Thermo Fisher Scientific has expanded its sterile manufacturing and research capabilities in the Asia-Pacific region with the opening of a new sterile drug facility in Singapore. The new good manufacturing practices facility was established with support from the Singapore Economic Development Board. It comes with quick vaccine fill-finish capabilities and offers end-to-end pharmaceutical development and manufacturing services.
How the digital front door benefits clinical trial patients, clinicians and sponsors
Bio Pharma Dive
MAY 22, 2023
A digital front door in clinical trials is a triple win that improves patient and clinician satisfaction, data quality and costs.
UK takes measures to tackle Utrogestan hormone replacement shortage
Pharmaceutical Technology
MAY 22, 2023
As supplies for Besins Healthcare’s hormone replacement therapy (HRT) medication Utrogestan (progesterone) experience shortages in the UK, the Department of Health and Social Care has issued a Serious Shortage Protocol (SSP) addressing the measures being made to mitigate the issue. Utrogestan is a medication used to treat several conditions in women’s health such as polycystic ovarian syndrome (PCOS), prevention of preterm birth in women, and menopausal disorders.
May 22, 2023: EMBED Finds Racial and Ethnic Differences in Buprenorphine Initiation for Opioid Use Disorder
Rethinking Clinical Trials
MAY 22, 2023
In a secondary analysis from the EMBED pragmatic clinical trial, Black patients with opioid use disorder were less likely than White patients to be initiated on buprenorphine in the emergency department. The study’s findings were published recently in Academic Emergency Medicine. EMBED, an NIH Collaboratory Demonstration Project, was a cluster randomized trial across 21 emergency departments in 5 healthcare systems in the United States.
2022 Research: The Rapid Rise of Ocean Freight Visibility
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
UK to provide up to £39m for AMR research
Pharmaceutical Technology
MAY 22, 2023
The UK government has announced that it will provide up to £39m in funding to conduct research for developing new treatments for antimicrobial resistance (AMR), which is also called ‘the silent killer’. The funding for the research programme will be provided under the government’s Global AMR Innovation Fund. Up to £24m will be provided over a period of four years to strengthen the UK’s collaboration with the global AMR research initiative, CARB-X.
Blueprint's Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis
Fierce Pharma
MAY 22, 2023
Blueprint's Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis zbecker Mon, 05/22/2023 - 14:43
US FDA approves Krystal Biotech’s Vyjuvek for DEB
Pharmaceutical Technology
MAY 22, 2023
The US Food and Drug Administration (FDA) has granted approval for Krystal Biotech’s Vyjuvek (beremagene geperpavec-svdt) to treat dystrophic epidermolysis bullosa (DEB) in patients aged six months and above. Vyjuvek is a non-invasive, topical, re-dosable gene therapy that delivers functional human COL7A1 gene copies to offer wound healing. It is claimed to be both the first re-dosable gene therapy and the first and only FDA-approved treatment for both recessive and dominant types of DEB, a rare
DrugChatter.com: AI Chat for Biopharmaceutical Drug Insights
Drug Patent Watch
MAY 22, 2023
Introducing DrugChatter.com: Empowering Access to Biopharmaceutical Drug Insights through AI Chat We are pleased to introduce DrugChatter.com, a groundbreaking platform that redefines the way professionals obtain concise, cited information on… The post DrugChatter.com: AI Chat for Biopharmaceutical Drug Insights appeared first on DrugPatentWatch - Make Better Decisions.
An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space
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
Ironwood Pharmaceuticals agrees to buy VectivBio for $1bn
Pharmaceutical Technology
MAY 22, 2023
Ironwood Pharmaceuticals has entered into a definitive agreement to buy Swiss biopharmaceutical company VectivBio in an all-cash deal valued at around $1bn. Ironwood will start a tender offer to purchase all outstanding ordinary VectivBio shares for $17.00 per share in cash. VectivBio is focused on the discovery, development and commercialisation of treatments for many rare conditions, including acute graft versus host disease and short bowel syndrome with intestinal failure (SBS-IF).
Vital patent for AlzeCure Alzheimer’s drug
Pharma Times
MAY 22, 2023
ACD856 is the leading candidate therapy on the company’s NeuroRestore platform
Biogen and Eisai seek UK’s marketing authorisation for lecanemab
Pharmaceutical Technology
MAY 22, 2023
Biogen and Eisai have submitted a marketing authorisation application (MAA) to the UK’s medicines and healthcare products regulatory agency (MHRA) for lecanemab to treat early Alzheimer’s disease (AD). Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody that will be used to treat mild cognitive impairment caused due to AD and mild AD dementia in people with the confirmed presence of amyloid pathology in the brain.
Bayer's blockbuster hopeful Nubeqa, AstraZeneca's Forxiga pick up nods from England's NICE
Fierce Pharma
MAY 22, 2023
Bayer's blockbuster hopeful Nubeqa, AstraZeneca's Forxiga pick up nods from England's NICE zbecker Mon, 05/22/2023 - 10:44
Mandatory COVID Vaccination Policy Template
Advertiser: Aggregage
New vaccine mandates and testing policies will affect employers with more than 100 workers. Get Paycor’s free, customizable vaccination policy template to communicate critical details and new requirements to your employees. Get Paycor’s Template today!
FDA approves AbbVie-Genmab’s Epkinly to treat DLBCL
Pharmaceutical Technology
MAY 22, 2023
The US Food and Drug Administration (FDA) has granted approval to AbbVie and Genmab ‘s Epkinly (epcoritamab-bysp) to treat relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adult patients. Epkinly has been approved as the first and only T-cell-engaging bispecific antibody to treat adults with DLBCL not otherwise specified (NOS), including DLBCL arising from indolent lymphoma and high-grade B–cell lymphoma (HGBL), following two or more lines of systemic therapies.
How to get the most out of your clinical trial search
Antidote
MAY 22, 2023
Participating in a clinical trial can be a worthwhile opportunity for any individual. Whether taking part as a healthy volunteer or enrolling in a study for a specific condition, being a medical research participant can provide the chance to be more involved in medical treatments, gain access to potential new therapies, and pave the way for medical breakthroughs to take place.
How Pairwise Leverages CRISPR Technology for Leafy Greens
XTalks
MAY 22, 2023
Pairwise , a startup based in Durham, North Carolina, has launched its first CRISPR-developed product in the US: Conscious Greens. Touted as a mix of superfood leafy greens, the product claims to offer twice the nutrition of traditional romaine lettuce and comes with an appealing fresh flavor. This product is notable because the company claims it’s the first food product in the US that was developed using CRISPR technology.
Insmed unveils new research platforms and capabilities
BioPharma Reporter
MAY 22, 2023
US biopharma Insmed has announced progress across its early-stage research programs at the company's investor and analyst event, The Future of Rare at Insmed: Functional Genes, AI-Enhanced Proteins, Glowing Algae, and More.
Eisai makes lecanemab therapy application
Pharma Times
MAY 22, 2023
Treatment involves early Alzheimer’s disease and will be potentially used across Great Britain
Pfizer, Moderna among many biopharma giants to post Q1 sales declines, as Novo Nordisk led growth charge
Fierce Pharma
MAY 22, 2023
Pfizer, Moderna among many biopharma giants to post Q1 sales declines, as Novo Nordisk led growth charge kdunleavy Mon, 05/22/2023 - 13:04
SkinVive by Juvéderm: The New Dermal Filler Coming to the US
XTalks
MAY 22, 2023
Allergan Aesthetics, an AbbVie company renowned for its development of leading aesthetics brands and products, recently announced the US Food and Drug Administration (FDA) approved their ground-breaking hyaluronic acid product, SkinVive by Juvéderm, for achieving remarkable skin smoothness. SkinVive is FDA-approved for all Fitzpatrick skin types I to VI (lightest to darkest), addressing a range of skin quality concerns.
With Dupixent leading the way, Sanofi’s taking on the 'big players' in respiratory diseases: exec
Fierce Pharma
MAY 22, 2023
With Dupixent leading the way, Sanofi’s taking on the 'big players' in respiratory diseases: exec kdunleavy Mon, 05/22/2023 - 07:33
uBriGene targets North American growth with buy of Mustang Bio facility
BioPharma Reporter
MAY 22, 2023
uBriGene is expanding into the US market with the acquisition of a state-of-the-art GMP manufacturing facility from Mustang Bio.
PBMs and the Battle Over Patient Support Funds:Accumulators, Maximizers, and Alternative Funding (NEW Live Video Webinar)
Drug Channels
MAY 22, 2023
Dr. Adam J. Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for a new video webinar: PBMs and the Battle Over Patient Support Funds: Accumulators, Maximizers, and Alternative Funding This event will be broadcast live on Friday, June 23, 2023, from 12:00 p.m. to 1:30 p.m. ET. This page describes the event and explains how to purchase a registration.
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