Industry News

Lonza has launched a new capsule to deliver acid-sensitive APIs to the intestine.

Updates to general chapters on compounding, <795> Nonsterile Preparations and <797> Sterile Preparation, include requirements for equipment, cleaning, personnel garb, labeling, and surface contamination testing.

FDA has accepted Ashland’s Viatel bioresorbable mPEG-PDLLA pharmaceutical excipient into the FDA Novel Excipient Review Pilot Program.

A possible change in leadership on Capitol Hill has aggravated fears of political push-back on FDA regulation and approval of contraceptives and other medications.

Roquette has launched excipients PEARLITOL CR-H and PEARLITOL 200 GT.

The CPHI Annual Report 2022 predicts cash reserves from venture capitalists and private equities will drive expansion in the demand for contract research organizations and contract development and research organizations.

AstraZeneca’s Imjudo (tremelimumab) was approved by FDA in combination with Imfinzi (durvalumab) for treating unresectable liver cancer.

An advisory committee’s vote to remove Makena from the market illustrates how difficult it is for regulators to ensure that such drugs document safety and effectiveness in a timely manner.

Cambrex has expanded its stability storage business, Q1 Scientific, in Ireland and Belgium.

Pharma supply chains are no longer hidden beyond the reach of ESG agendas, making it important for companies to accelerate adoption of new manufacturing processes and environmental technology

AAPS will exclusively advise RX Global on scientific focus areas for Interphex 2023, which is set to take place at the Javits Center in New York City next spring.

The agency has recommended approval of Comirnaty and Spikevax for children from six months of age.

The agency has recommended authorization of the Spikevax COVID-19 vaccine that targets the Omicron variants BA.4 and BA.5.

FDA amended its authorization for the Moderna and Pfizer-BioNTech bivalent booster vaccines to permit their use in children as young as five years old.

Russell Kneipp, who has been Spectrum’s COO since 2018, will assume the roles effective immediately.

CRB’s Horizons: Life Sciences report covers challenges facing manufacturers and how to keep pace with rapid innovation.

CBER maps modernization plan to handle surge in research and applications.

The UK’s MHRA has approved Colonis’ melatonin oral solution for sleep onset insomnia in children and adolescents with ADHD.

H.I.G. Capital’s portfolio company Aspire Pharma has acquired Morningside Healthcare and Morningside Pharmaceuticals.

Klucel xtend HPC is the latest addition to the company’s Klucel product line and further expands their controlled-release portfolio.

FDA has granted Fast Track designation for CUE-101, a treatment of recurrent/metastatic head and neck squamous cell carcinoma.

Pfizer has completed its acquisition of Biohaven Pharmaceuticals for approximately $11.6 billion.

PerkinElmer has unveiled a cell analysis solution to streamline cell and gene therapy research and manufacturing.

FDA is highlighting how the Patient-Focused Drug Development program has encouraged active involvement of many patient groups in bringing their perspectives into the process of developing, testing, and approving new medicines.

Biogen has agreed to pay $900 million to settle federal and state claims that it paid kickbacks to physicians to encourage them to prescribe its drugs.

A combination of eye imaging techniques and adaptive optics has revealed key details of choroideremia.

Actylis combines Aceto and its 10 acquired specialists into a singular global brand.

Pfizer is set to supply global fund up to 6 million treatment courses of its COVID-19 oral treatment, PAXLOVID, for low-and-middle-income countries.

Aprecia has hired Chris Lockwood as head of technical services at its Ohio facility.

Legislative leaders are looking to approve a bare-bones measure to fund FDA operations as part of a short-term government funding bill.