Pharma News

Sun Pharma announced that one of its wholly-owned subsidiaries has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for generic Amphotericin B Liposome for Injection, 50 mg/vial Single-Dose Vial. The generic product approval is based on AmBisome® Liposome for Injection, 50 mg/vial as a reference product.

Sun Pharma has been granted Competitive Generic Therapy (CGT) designation by US FDA and being the first approved generic, is eligible for 180 days of CGT exclusivity for the product.

Zydus, a leading discovery-based, global pharmaceutical company announced today that it has received permission to initiate the Phase II (a) clinical study of its NLRP3 inhibitor ZYIL1 in patients with Cryopyrin-Associated Periodic Syndrome (CAPS) in Australia. Phase II (a) clinical trial in Australia will study the safety, tolerability, pharmacokinetics and pharmacodynamics in patients with Cryopyrin- Associated Periodic Syndrome (CAPS).

PCI Pharma Services (PCI), a leading global contract development and manufacturing organization (CDMO), today announced the closing of the previously announced acquisition of Lyophilization Services of New England, Inc. (LSNE), a premier contract development and manufacturing organization headquartered in Bedford, New Hampshire.

The newly relaunched device is a handheld, lightweight solution that improves breathing and strengthens the lungs. With AirPhysio, chronic bronchitis sufferers can reduce mucus buildup in five minutes or less per day.

Lupin Limited (Lupin) has received the Establishment Inspection Report (EIR) from United States Food and Drug Administration (US FDA) for its Goa manufacturing facility, after the inspection of the facility in September 2021. The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI).

OKYO Pharma Limited a biotechnology company focused on the discovery and development of novel molecules to treat inflammatory dry eye diseases (DED) and ocular pain, is pleased to announce that its drug candidate OK-101 which was developed to treat DED through its anti-inflammatory mode of action also shows potent ocular pain reducing property determined using a mouse model of corneal neuropathic pain, establishing the potential to treat both pain and inflammation, the most common symptoms of dry eye, with a single drug.

Acacia Pharma Group plc a commercial stage biopharmaceutical company focused on developing and commercializing novel products to improve the care of patients undergoing serious medical treatments such as surgery, invasive procedures, or cancer chemotherapy, announces the successful completion of its post-approval requirement clinical trial investigating the effects of BARHEMSYS® (amisulpride injection) in individuals with severe renal impairment.

A study of an investigational gene therapy for sickle cell disease has found that a single dose restored blood cells to their normal shape and eliminated the most serious complication of the disease for at least three years in some patients.

An experimental HIV vaccine based on mRNA—the same platform technology used in two highly effective COVID-19 vaccines—shows promise in mice and non-human primates, according to scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Their results, published in Nature Medicine, show that the novel vaccine was safe and prompted desired antibody and cellular immune responses against an HIV-like virus.