Fri.Dec 02, 2022

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Rigel wins US approval of rival drug to Servier leukemia treatment

Bio Pharma Dive

The approval gives Rigel, a biotech that’s been around since the mid-1990s, its second marketed medicine and a competitor to Servier’s Tibsovo

Marketing 255
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How to cut drug supply costs with seamless forecasting and IRT systems

Pharmaceutical Technology

An accurate drug supply forecast is essential for a successful clinical trial. Without it, sponsors risk a shortage of investigative medicinal product (IMP) for patients, resulting in major trial delays.

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FDA lifts pause on Beam plans to test base editing cancer therapy

Bio Pharma Dive

The FDA’s decision is a step forward for a type of drugmaking known as “multiplex editing,” which involves editing several genes simultaneously

Gene 250
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India’s CDSCO approves Bharat Biotech’s intra-nasal vaccine for Covid-19

Pharmaceutical Technology

India’s Central Drugs Standard Control Organisation (CDSCO) has granted approval for Bharat Biotech’s BBV154 vaccine for treating Covid-19. BBV154 is claimed to be the first intra-nasal vaccine for Covid-19 in the world.

Licensing 188
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2022 Research: The Rapid Rise of Ocean Freight Visibility

Download this a benchmark study from FourKites and The Journal of Commerce exploring how international shippers’ usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19.

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J&J’s Duato to replace departing Gorsky as board chair

Bio Pharma Dive

The board reshuffling will consolidate Duato’s leadership of J&J as the company absorbs a big medtech acquisition and nears a planned spin out of its consumer health division

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How an innovative new bioreactor is using ultra-fine filters to increase T-cell production

Pharmaceutical Technology

Cell cultivation is labour-intensive and includes many open process steps requiring expensive cleanroom procedures once the transition to clinical production is made. Consequently, there is an urgent need for efficient production platforms at scale.

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PTC Therapeutics’ Waylivra receives Brazilian regulatory approval

Pharmaceutical Technology

PTC Therapeutics has received approval from the Brazilian health regulatory agency, ANVISA, for Waylivra (volanesorsen) to treat familial partial lipodystrophy (FPL). This is marked as the first approval for Waylivra for the indication worldwide.

Licensing 130
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Healthcare leaders warn about unsustainable pressure on mental health services

Pharma Times

Patients and service users routinely struggle to access mental healthcare across the NHS

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With buyout on Horizon, Amgen and Sanofi eye cash plays for rare disease drug maker

Fierce Pharma

With buyout on Horizon, Amgen and Sanofi eye cash plays for rare disease drug maker. fkansteiner. Fri, 12/02/2022 - 09:51

Drugs 98
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Merck KGaA’s arpraziquantel validated by European Medicines Agency

Pharma Times

Positive scientific opinion by EMA would create pathway for arpraziquantel in African endemic countries

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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Currently in sales or involved in a business that depends on strong sales results? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC. You will absorb critical strategies to become a trusted partner in greater sales success.

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AMGEN PRESENTS NEW AMG 133 PHASE 1 CLINICAL DATA AT WCIRDC 2022

The Pharma Data

AMGEN PRESENTS NEW AMG 133 PHASE 1 CLINICAL DATA AT WCIRDC 2022. Amgen (NASDAQ:AMGN) today announced new Phase 1 data from AMG 133, a novel bispecific glucose-dependent insulinotropic polypeptide receptor (GIPR) antagonist and glucagon-like peptide-1 (GLP-1) receptor agonist molecule. This first-in-human study was designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of AMG 133 in people with obesity and without diabetes (NCT04478708).

Insulin 63
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UPDATED: GSK, with new trial win, looks to expand PD-1 Jemperli in endometrial cancer

Fierce Pharma

UPDATED: GSK, with new trial win, looks to expand PD-1 Jemperli in endometrial cancer. zbecker. Fri, 12/02/2022 - 11:22

Trials 87
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Lilly Completes Acquisition of Akouos Expanding Efforts to Help People with Genetic Diseases

The Pharma Data

Lilly Completes Acquisition of Akouos Expanding Efforts to Help People with Genetic Diseases. Eli Lilly and Company (NYSE: LLY) announced the successful completion of its acquisition of Akouos, Inc. NASDAQ: AKUS). The acquisition expands Lilly’s efforts in genetic medicines to include Akouos’s portfolio of potential first-in-class adeno-associated viral gene therapies for the treatment of inner ear conditions, including sensorineural hearing loss.

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Improving trial predictability: leveraging AI-powered analytics to guide trial design, strategy, and operations

Pharma Phorum

Enrolling for clinical trials has become more challenging in recent years, with trial competition, increasingly complex protocols, and precision medicine targeting more niche patient populations. This emphasises sponsors’ need for enrolment predictability.

Trials 83
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Mandatory COVID Vaccination Policy Template

The federal government is developing a rule requiring employers with more than 100 employees ensure their workers are vaccinated or produce a negative COVID test weekly before entering the workplace. So, what can your organization do to prepare? Get Paycor’s COVID Vaccination Policy Template to help communicate important details to your employees.

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Sanofi to showcase new data from oncology portfolio spanning marketed products and investigational compounds at ASH 2022

The Pharma Data

Sanofi to showcase new data from oncology portfolio spanning marketed products and investigational compounds at ASH 2022. Data featured at the 64 th American Society of Hematology (ASH) Annual Meeting & Exposition from December 10-13, 2022, reinforce Sanofi’s commitment to transforming care for people living with multiple myeloma (MM) and other difficult-to-treat blood cancers. Peter C.

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Fierce Pharma Asia—Eisai's lecanemab Alzheimer's debate; BeiGene's Imbruvica showdown; Shionogi's COVID drug nod

Fierce Pharma

Fierce Pharma Asia—Eisai's lecanemab Alzheimer's debate; BeiGene's Imbruvica showdown; Shionogi's COVID drug nod. Fri, 12/02/2022 - 08:55

Drugs 82
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Merck to Present Data From Its Hematology Portfolio and Promising Pipeline at the 64th American Society of Hematology (ASH) Annual Meeting

The Pharma Data

Merck to Present Data From Its Hematology Portfolio and Promising Pipeline at the 64th American Society of Hematology (ASH) Annual Meeting. RAHWAY, N.J.–(BUSINESS –(BUSINESS WIRE)– Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the presentation of findings from clinical trials and real-world studies at the upcoming 64 th American Society of Hematology (ASH) Annual Meeting from Dec. 10-13, 2022, in New Orleans, Louisiana and virtually.

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Merck, BigHat BioSciences Collaborate on Drug Discovery Programs

Pharmaceutical Commerce

Biotech company’s AI/machine learning-enabled platform to design candidates for up to three drug discovery programs.

Drugs 52
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European Medicines Agency accepts marketing authorization application for momelotinib for the treatment of myelofibrosis

The Pharma Data

European Medicines Agency accepts marketing authorization application for momelotinib for the treatment of myelofibrosis. GSK plc (LSE/NYSE: GSK). announced that the European Medicines Agency (EMA) validated the marketing authorisation application (MAA) for momelotinib, a potential new oral treatment for myelofibrosis.

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AstraZeneca, MSD raise prostate cancer awareness with ‘Never Miss’ campaign

Pharma Phorum

A new global prostate cancer awareness campaign developed by biopharmaceutical companies AstraZeneca (AZ) and Merck & Co.

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Jemperli (dostarlimab) RUBY phase III trial met its primary endpoint in a planned interim analysis in patients with primary advanced or recurrent endometrial cancer

The Pharma Data

Jemperli (dostarlimab) RUBY phase III trial met its primary endpoint in a planned interim analysis in patients with primary advanced or recurrent endometrial cancer.

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Gilead gets a leg up in dueling Truvada patent feuds with feds

Fierce Pharma

Gilead gets a leg up in dueling Truvada patent feuds with feds. fkansteiner. Fri, 12/02/2022 - 08:37

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ANNOUNCEMENT FOR THE PURPOSES OF RULE 2.12 OF THE IRISH TAKEOVER PANEL ACT

The Pharma Data

ANNOUNCEMENT FOR THE PURPOSES OF RULE 2.12 OF THE IRISH TAKEOVER PANEL ACT. Further to the announcement made by Horizon under Rule 2.4 of the Irish Takeover Rules on November 29, 2022, Amgen confirms for the purposes of Rule 2.12 of the Irish Takeover Rules that any offer by Amgen for Horizon is, or is likely to be, solely in cash. Accordingly, there are no disclosure requirements under Rule 8.3(a) a) of the Irish Takeover Rules in relation to relevant securities of Amgen.

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Rigel scores green light in AML just 4 months after buying asset from Forma

Fierce Pharma

Rigel scores green light in AML just 4 months after buying asset from Forma. kdunleavy. Fri, 12/02/2022 - 10:00

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Nanotech strategy shows promise for treating autoimmune disease

The Pharma Data

Nanotech strategy shows promise for treating autoimmune disease. Scientists at Scripps Research have reported success in initial tests of a new, nanotech-based strategy against autoimmune diseases. The scientists, who reported their results on November 23, 2022, in the journal ACS Nano, engineered cell-like “nanoparticles” that target only the immune cells driving an autoimmune reaction, leaving the rest of the immune system intact and healthy.

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FDA Approves Rebyota as First Fecal Microbiome Therapy for Recurrent C. Difficile Infection

XTalks

Swiss company Ferring Pharmaceuticals has won a historic approval from the US Food and Drug Administration (FDA) for its fecal transplant-based therapy Rebyota (fecal microbiota, live-jslm) to reduce the recurrence of bacterial infection. The therapy is the first of its kind to be approved in the US.

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Eisai’s full lecanemab phase 3 trial results for Alzheimer’s presented at CTAD

Pharma Phorum

Following the news of two lecanemab-related deaths reported on the eve of the Clinical Trials on Alzheimer’s Disease (CTAD) 2022 conference, Eisai has now presented the full results from its phase 3 confirmatory Clarity AD study for early Alzheimer’s disease and published them in the New England Journal of Medicine (NEJM).

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New patent for Belcher drug EPINEPHRINE

Drug Patent Watch

Annual Drug Patent Expirations for EPINEPHRINE Epinephrine is a drug marketed by Armstrong Pharms, Belcher, Intl Medication Sys, Am Regent, Hospira, and Teva Pharms Usa and, and is included in….

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Health Innovators – Monique Levy

Pharma Phorum

In this bonus interview from Frontiers Health 2022, provided by our partners at Healthware, pharmaphorum Founder Paul Tunnah chats with Woebot Health Chief Business Officer Monique Levy about her work in AI for mental health.

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New patent for Pacira Pharms drug EXPAREL

Drug Patent Watch

Annual Drug Patent Expirations for EXPAREL Exparel is a drug marketed by Pacira Pharms Inc and is included in one NDA. It is available from one supplier. There are eight…. The post New patent for Pacira Pharms drug EXPAREL appeared first on DrugPatentWatch - Make Better Decisions. Patent Added

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Hired and retired: New appointments in the biopharma industry

BioPharma Reporter

Moderna, Rentschler Biopharma and ViroCell Biologics are among the companies welcoming new faces to top jobs. Biopharma Culture

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New patent for Aveo Pharms drug FOTIVDA

Drug Patent Watch

Annual Drug Patent Expirations for FOTIVDA Fotivda is a drug marketed by Aveo Pharms and is included in one NDA. It is available from one supplier. There are two patents…. The post New patent for Aveo Pharms drug FOTIVDA appeared first on DrugPatentWatch - Make Better Decisions. Patent Added

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ADDF: Anti-amyloids are a promising starting point

BioPharma Reporter

The phase 3 trial results for lecanemab and gantenerumab presented at the Clinical Trials on Alzheimerâs Disease (CTAD) conference demonstrate why optimal treatment of Alzheimerâs will require drugs that do more than clear amyloid plaques, says the Alzheimerâs Drug Discovery Foundation (ADDF).

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New patent for SPIL drug ASPRUZYO SPRINKLE

Drug Patent Watch

Annual Drug Patent Expirations for ASPRUZYO+SPRINKLE Aspruzyo Sprinkle is a drug marketed by Spil and is included in one NDA. It is available from one supplier. There is one patent…. The post New patent for SPIL drug ASPRUZYO SPRINKLE appeared first on DrugPatentWatch - Make Better Decisions.