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Homepage > Company > Media > Pharma News > 2022

Pharma News, 2022

FDA Grants Breakthrough Therapy Status to Iveric Bio’s Zimura for AMD

FDA Grants Breakthrough Therapy Status to Iveric Bio’s Zimura for AMD

The FDA has granted Breakthrough Therapy status for Iveric Bio’s Zimura (avacincaptad pegol) for geographic atrophy secondary to age-related macular degeneration (AMD) which leads to progre...

Merck bulks up in haematology, buying Imago for $1.35bn

Merck bulks up in haematology, buying Imago for $1.35bn

While its fabled takeover of Seagen is yet to materialise, Merck & Co has continued to bolster its pipeline with smaller deals – with its latest a $1.35 billion agreement to buy Imago BioScie...

Anti-Amyloid-ß Oligomer Antibody ACU193 Gains FDA Fast Track Designation

Anti-Amyloid-ß Oligomer Antibody ACU193 Gains FDA Fast Track Designation

ACU193, an antibody developed based on its selectivity for soluble amyloid-ß oligomers, is currently being assessed in a phase 1 trial, with a potential phase 2/3 trial in the near future. ...

Regeneron, CytomX announce bispecific therapeutics for cancer collab

Regeneron, CytomX announce bispecific therapeutics for cancer collab

Regeneron Pharmaceuticals, Inc. and CytomX Therapeutics, Inc. have announced a strategic research collaboration within the field of conditionally activated bispecific therapeutics for the treatmen...

FDA Approves Second Interchangeable Insulin Product, Rezvoglar (insulin glargine-aglr)

FDA Approves Second Interchangeable Insulin Product, Rezvoglar (insulin glargine-aglr)

The U.S. Food and Drug Administration approves the second interchangeable biosimilar insulin product to Lantus (insulin glargine), Eli Lilly’s Rezvoglar (insulin glargine-aglr). ...

Tzield drug that can delay onset of type 1 diabetes has a pricetag close to $200,000

Tzield drug that can delay onset of type 1 diabetes has a pricetag close to $200,000

The FDA has approved Provention Bio’s Biologics License Application (BLA) for Tzield (teplizumab-mzwv) to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients eight years a...

Camber Pharmaceuticals Launches Generic Lamictal XR

Camber Pharmaceuticals Launches Generic Lamictal XR

Camber Pharmaceuticals is pleased to announce the addition of Lamotrigine ER Tablets to its current portfolio.

Novel AI blood test detects liver cancer

Novel AI blood test detects liver cancer

A novel artificial intelligence blood testing technology developed and used by Johns Hopkins Kimmel Cancer Center researchers to successfully detect lung cancer in a 2021 study has now detected mor...

NICE rejects five COVID drugs and backs three on price, efficacy data

NICE rejects five COVID drugs and backs three on price, efficacy data

NICE has recommended that three COVID-19 therapies can continue to be used to treat patients – Pfizer’s Paxlovid, Roche’s RoActemra, and Eli Lilly’s Olumiant – but turned down another fiv...

FDA Adds/Revises Product-Specific Guidances

FDA Adds/Revises Product-Specific Guidances

The FDA has issued 29 new product-specific draft guidances and 22 revised draft guidances for complex and non-complex generic drug products.

FDA panel backs Ardelyx CKD drug, despite agency concerns

FDA panel backs Ardelyx CKD drug, despite agency concerns

While the FDA seems to remain sceptical about the clinical benefits of Ardelyx’s chronic kidney disease (CKD) therapy Xphozah – having rejected its marketing application in 2021 – its adviso...

FDA May Approve Naloxone for Nonprescription Use

FDA May Approve Naloxone for Nonprescription Use

The FDA is considering whether some versions of the overdose reversal drug naloxone may be approvable for nonprescription use.

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