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Category: News


News

AbbVie breaks new ground for IL-23 drug Skyrizi in IBD

June 20, 2024

Via: Pharmaphorum

Skyrizi (risankizumab) was previously already cleared by the FDA for adults with moderately to severely active Crohn’s disease, active psoriatic arthritis, and moderate to severe plaque psoriasis. The approval in UC is based on the results of a 12-week induction study called […]


News

Study finds low secondary cancer risk with CAR-Ts

June 17, 2024

Via: Pharmaphorum

Last November, the FDA issued a warning about a risk of secondary cancers – particularly T-cell cancers – and earlier this year it requested a change to safety labelling to include a ‘black box’ warning on all six of the […]


News

Drug Shortage Reports Emphasize Continuing Problems

June 11, 2024

Via: Biopharm International

In early June 2024, FDA and the US Pharmacopeial Convention (USP) both published reports on drug shortages as of the end of 2023. The Center for Drug Evaluation and Research at FDA published its 11th annual report to Congress on […]


News

Abbott’s OTC glucose monitor ‘will grow the market’

June 4, 2024

Via: Pharmaphorum

Abbott hasn’t issued a public statement on the 510k approval, which has just been published on the FDA’s website, but the wearable device has a similar indication to Stelo and can be used in both non-insulin-dependent type 2 diabetics as […]


News

Lilly’s Retevmo cleared for RET-positive child cancers

May 30, 2024

Via: Pharmaphorum

Retevmo (selpercatinib) can now be used to treat RET-positive thyroid cancers and other solid tumours with the mutation, regardless of their type. Specifically, the new indication covers advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, advanced or […]


News

New ‘plug and play’ system to offer novel way of delivering vaccines and treatments

May 22, 2024

Via: Pharma Times

A new technology developed by researchers from King’s College London (KCL) could provide a new way of delivering drugs to advance next-generation treatments to prevent and treat a variety of diseases. Published in the nanotechnology journal Small, the ‘plug and […]


News

Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges

May 6, 2024

Via: Biopharm International

Sterility must be assured for all biologic drug products. Terminal sterilization achieved via treatment with heat, radiation, or certain chemicals (vaporous hydrogen peroxide, vaporous peracetic acid, or ethylene oxide) is preferred, but it is only applicable to drug substances that […]


News

FDA Says First Round of Tests Show No Live Virus in Pasteurized Milk

April 29, 2024

Via: Drugs.com

Live bird flu virus has not been found in any of the first batch of retail milk samples tested, federal health officials said Friday. Amid an ongoing outbreak of bird flu in U.S. dairy cows, the early findings should reassure […]


News

Carvykti, Abecma move earlier in multiple myeloma treatment

April 8, 2024

Via: Pharmaphorum

The decision came right after the US regulator also cleared Bristol-Myers Squibb and 2seventy bio’s rival CAR-T Abecma as a third-line therapy for relapsed or refractory multiple myeloma, moving the cell therapies much earlier in the treatment pathway from their […]


News

High-Strength Lidocaine Skin Creams Can Cause Seizures, Heart Trouble, FDA Warns

March 29, 2024

Via: Drugs.com

Some pain-relieving skin products contain potentially harmful doses of the numbing agent lidocaine and should be avoided, the U.S. Food and Drug Administration warns. These creams, gels, sprays and soaps are marketed for topical use to relieve the pain of […]


News

Ensuring Contractors Perform Good Distribution Practices

March 1, 2024

Via: Biopharm International

The number of contractors and subcontractors involved in the supply chain for finished goods can be high, and their relationships very complex, particularly when goods are shipped by air or sea. Depending on the scope of the activity (e.g., whether […]


News

Can a Moderna co-founder change the CRO game?

February 29, 2024

Via: Biopharma Dive

When you’re looking to make changes to how clinical trials are run, it’s helpful to work with one of the top minds in the industry. By welcoming Robert Langer to its advisory board, that’s exactly what Lindus Health hopes to […]


News

FDA approves Allecra’s combination antibiotic Exblifep for complicated UTIs

February 28, 2024

Via: PMLiVE

The antibiotic combination has been approved for adults with cUTIs, including the kidney infection pyelonephritis, which is most commonly caused by gram-negative bacteria. UTIs are a common infection and typically require antibiotics for treatment. Accounting for approximately 19% of all […]


News

UK biotech Curve swings £40.5m in Pfizer-backed round

February 27, 2024

Via: Pharmaphorum

The round was led by Pfizer’s investment arm Pfizer Ventures, with Columbus Venture Partners and British Patient Capital joining the round along with prior investors Advent Life Sciences and Epidarex Capita. The proceeds will be used to develop Curve’s Microcycle […]


News

NGM to go private through deal with investment firm

February 26, 2024

Via: Biopharma Dive

Founded in 2007, NGM took a broad approach to its drug research, assembling a pipeline that spans from solid tumors to retinal diseases to liver and metabolic disorders. NGM raised a few hundred million dollars in private funding before going […]


News

FDA starts review of Argenx drug in rare disease CIDP

February 20, 2024

Via: Pharmaphorum

If approved, Vyvgart Hytrulo (efgartigimod alfa) will be the first drug in the FcRn blocker class to treat CIDP, a rare autoimmune disease of the peripheral nervous system that causes fatigue, muscle weakness, and loss of feeling that can lead […]


News

First drug therapy for frostbite has been cleared by FDA

February 15, 2024

Via: Pharmaphorum

The US regulator has cleared Aurlumyn (iloprost) injection from CiVi Biopharma subsidiary Eicos Sciences as a treatment for severe frostbite, caused by prolonged exposure to extreme cold, after a priority review. The incidence of severe frostbite injury in the US […]


News

LianBio to shut down, return cash to investors

February 14, 2024

Via: Biopharma Dive

LianBio had a busy end to 2023. In October, the biotech sold its marketing rights to the heart medicine mavacamten in Asian countries to Bristol Myers Squibb for $350 million. Not long after, the company received an unsolicited bid from […]


News

Khosla Ventures’ Alex Morgan on biotech’s challenges and solving drug delivery

February 6, 2024

Via: Biopharma Dive

To hear venture capitalist Alex Morgan tell it, investors shouldn’t be in the business of predicting trends. “There’s often a public perception that we’re in the prediction game,” said Morgan, a partner at Khosla Ventures who oversees the firm’s biotechnology […]


News

FDA sets date for Adaptimmune’s sarcoma drug verdict

February 2, 2024

Via: Pharmaphorum

If the biologics license application (BLA) is approved, afami-cel will become the first engineered T-cell therapy for solid tumours and the first effective treatment option for advanced synovial sarcoma in more than a decade, according to the Anglo-American company. Synovial […]