Industry News

A statement from FDA Commissioner Scott Gottlieb and Deputy Commissioner Anna Abram detailed FDA’s new plan to advance plant and animal biotechnology innovation.

The latest CPhI Worldwide survey results have revealed a promising outlook for the global pharma economies.

Research from Massachusetts Institute of Technology suggests that small chips could replace standard lab-scale spectrometry equipment for many applications.

The agency, in partnership with international regulatory and law enforcement agencies, cracked down on 465 websites marketing illegal opioids and other drugs claiming to treat conditions such as cancer and HIV.

Takhzyro (lanadelumab) is the first monoclonal antibody therapy approved for the prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.

The recommended drugs include one biosimilar, two orphan medicines, and three extensions of therapeutic indication.

To achieve a more dynamic marketplace, FDA is issuingguidance documents and targeted advisories to support R&D on complex generics and combination products.

The US Department of Health and Human Services has published its proposed rule on the disclosure of drug prices, just in time for the November mid-term elections.

According to CPhI’s annual report, the therapeutic antibody drug conjugates (ADC) market is expected to reach $4 billion by 2023.

The agency is developing technology- and disease-specific regulatory frameworks for innovations that may not have previously had a clear development pathway.

The new guidance, Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings Guidance for Industry, discusses the planning of pre-IND meetings with FDA and sponsors.

A new investigational vaccine, LASSARAB, shows promise for use against Lassa fever and rabies.

Congress approves bills with provisions important to FDA and industry, some of which reflect continuing concerns about drug pricing and transparency.

The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation to seek views on how legislations and procedures of the agency may need to be modified should there be a ‘no-deal’ Brexit scenario.

Researchers who are younger than 35 years with an advanced degree and working within Europe will be able to apply for the award.

FDA is joining with other federal health agencies and the biomedical research community to advance the science, regulatory policies, and reimbursement strategies to support innovation in antimicrobials.

CPhI releases the bio trends portion of its annual report, which predicts an increase in bioconjucation expertise and biopharma productivity over the next five years.

The agency sent a warning letter to the Indian company after an inspection found CGMP violations that included a lack of written procedures and analytical testing.

The European Medicines Agency revised the number of centrally authorized medicines for which there are concerns over Brexit-related supply disruptions.

The agency announced that differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors.

The agency has entered into an agreement with the National Academies of Science, Engineering & Medicine and has expanded agreements with the University of Maryland and Johns Hopkins University Centers for Regulatory Science and Innovation to conduct research on the compounding of drugs.

The National Institute for Health and Care Excellence recently rejected National Health Service’s funding of Kymriah for diffuse large B-cell lymphoma (DLBCL) despite recognizing that the drug has significant clinical benefits.

Winners for each category will be revealed at the CPhI Pharma Awards Gala, taking place on Oct. 9, 2018.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended 13 new medicines for approval, including three orphan drug candidates.

FDA awarded nearly $3 million in grants for continuous manufacturing and other advanced manufacturing technologies as part of the agency’s efforts to ensure a robust and reliable supply of biological products.

Research by Thermo Fisher Scientific and LumaCyte suggests that LumaCyte's Radiance instrument offers the ability to rapidly analyze viral vaccines to speed development and production and ensure their effectiveness.

Colin Clarke, from the National Institute for Bioprocessing Research and Training, will lead a four-year European Industrial Doctoral Program for enhancing upstream biopharmaceutical manufacturing process development through single cell analysis.

FDA sent a warning letter to Lernapharm (Loris) Inc. detailing the company’s lack of procedures to prevent microbiological contamination.