Top

Category: News


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 […]


News

Novo resumes supplying starter doses of obesity drug Wegovy

January 31, 2024

Via: Biopharma Dive

Novo Nordisk has resumed shipping starter doses of its weight-loss drug Wegovy, nearly nine months after manufacturing problems forced it to restrict distribution to maintenance shots in order to ensure that people who had already started taking it could continue, […]


News

Merck pays $680M for struggling cancer biotech Harpoon

January 8, 2024

Via: Biopharma Dive

In 2028, Merck faces the possible loss of market exclusivity for its biggest product, Keytruda, which accounted for nearly half of its pharmaceutical revenue over the first nine months of 2023. Aiming to maintain its market share, Merck has been […]


News

Lead-Tainted Applesauce May Contain Another Toxin, Chromium

January 8, 2024

Via: Drugs.com

Applesauce fruit puree pouches under recall and investigation for toxic lead levels may also contain another toxin, chromium, according to an update released Friday by the U.S. Food and Drug Administration (FDA). The products under recall are WanaBana, Weis and […]


News

An unusual drugmaker raises north of $100M for ecstasy-based PTSD therapy

January 5, 2024

Via: Biopharma Dive

A California-based company has raised tens of millions of dollars to support its mission of bringing an ecstasy-based therapy to patients with post-traumatic stress disorder. MAPS Public Benefit Corp. formed a decade ago as a subsidiary of the Multidisciplinary Association […]


News

Goldman Sachs gets into biotech investing with new venture fund

January 3, 2024

Via: Biopharma Dive

Goldman’s foray into the biotech world shows continuing investor appetite in the venture capital arena, even while the public biotech market remains tepid. The last year featured a number of new VC fund launches, including from Dimension, Cure Ventures, Yosemite, […]


News

FDA ends busy year with three drug rejections

January 2, 2024

Via: Biopharma Dive

The Food and Drug Administration closed out 2023 with rejections of three drugmaker applications for first approval or expanded use, handing Amgen, Zealand Pharma and Merck & Co. complete response letters for medicines to treat cancer, low blood sugar and […]


News

Hemgenix first drug to clear France’s ‘direct access’ route

December 14, 2023

Via: Pharmaphorum

The route – which is being piloted for two years – allows drugs deemed to be innovative and with a major medical benefit by the Haute Autorité de Santé (HAS) to be made eligible for reimbursement by French social security […]


News

Colorado Blames Biden Team and Drugmakers for Delaying Canadian Imports

December 7, 2023

Via: Kaiser Health News

Colorado officials say their plan to import cheaper medicines from Canada has been stymied by opposition from drugmakers and inaction by the Biden administration, according to a state report obtained by KFF Health News. The Dec. 1 report, prepared for […]


News

FDA starts review of Padcev/Keytruda for bladder cancer

December 1, 2023

Via: Pharmaphorum

The agency is due to deliver a verdict on the combination by 9th May next year and, if approved, it could be an alternative to first-line chemotherapy for all patients with this form of cancer. Nectin-4-targeting antibody-drug conjugate Padcev (enfortumab […]


News

FTC challenges patents held by nine big drugmakers, citing unfair competition

November 8, 2023

Via: Biopharma Dive

The drugs targeted by FTC are largely older products that have retained some market power because competitors can’t easily duplicate their effectiveness when combined with a specialized delivery device. “Wrongfully listed patents can significantly drive up the prices Americans must […]