Regulations

FDA rebuff for Keytruda in breast cancer indication

30-Mar-2021 By Jane Byrne

A couple of new developments to report in relation to Merck, known as MSD outside the US and Canada: the first being the rejection by the US FDA of the company’s application to use its anti-PD-1 therapy, Keytruda, in certain breast cancer patients.

Amgen v Sanofi ruling: It is time to kiss goodbye to broad, functional patent claims for antibodies

25-Mar-2021 By Jane Byrne

A US court’s recent decision to find in favor of Sanofi and invalidate Amgen's broad antibody patent claims has biotech manufacturers concerned about how to preserve their IP.

FDA current COVID-19 updates, actions and advice

17-Mar-2021 By Jenni Spinner

As the vaccine goes into the arms of more people around the country, the US agency keeps on top of issues around the virus, offering resources and guidance.

Sagent issues voluntary recall of phenylephrine hydrochloride vials

15-Mar-2021 By Jenni Spinner

The company is recalling 10 mg/mL vials of phenylephrine hydrochloride due to potential lack of sterility assurance in several lots of the product.

US Army taps PPD to conduct PTSD treatment research

04-Mar-2021 By Jenni Spinner

The CRO will receive funding to fuel a five-year Research Project Award, with the goal to design and conduct research of potential PTSD treatment options.

SCOPE 2021

SCOPE 2021 to take on tough clinical trial challenges

24-Feb-2021 By Jenni Spinner

The annual event, moved to the virtual realm thanks to COVID-19, offers content on remote monitoring, drug development technology and other key topics.

Developing vaccines and therapeutics for virus variants: FDA releases new guidance

23-Feb-2021 By Rachel Arthur

The US Food and Drug Administration (FDA) has issued guidance for companies developing vaccines, diagnostics and therapeutics against new variants of SARS-CoV-2.

Quotient acquisition of Arcinova aimed at ‘streamlining’ early development process for biotech and pharma companies

18-Feb-2021 By Jane Byrne

Quotient Sciences, a drug development and manufacturing accelerator with facilities in the UK and the US, has acquired Arcinova, a UK-based multiservice contract development and manufacturing organization (CDMO).

Latest FDA COVID-19 updates and activity

09-Feb-2021 By Jenni Spinner

The federal agency continues to keep researchers, pharma firms and citizens apprised of current happenings and research related to the virus and pandemic.

Merck Digital Ethics Advisory Panel tackles tech questions

01-Feb-2021 By Jenni Spinner

The panel is intended to address ethical matters that arise around evolving data and digital conduct for all of its various business sectors.

Designated ‘Breakthrough Therapies’ draw support from Calyx

28-Jan-2021 By Jenni Spinner

The company’s medical imaging technology and other eClinical solutions reportedly played a part in half of the treatments to receive the FDA designation.

FDA COVID-19 responses and recommendations this week

28-Jan-2021 By Jenni Spinner

As the COVID-19 vaccines continue the early stages of circulation in the US, the agency keeps an eye on industry actions and offers advice to key players.

Continuus lands $69.3m US drug manufacturing contract

21-Jan-2021 By Jenni Spinner

The small-molecule pharmaceuticals manufacturer secured a DoD/HHS government contract to manufacture critical medicines for a range of conditions.

Fight against pharma counterfeiting must go deeper: TruTag

13-Jan-2021 By Jenni Spinner

A leader from the anti-counterfeit solutions firm says that while packaging-level efforts may have an effect, on-dose technology is worth a closer look.

Global alliance unites pharma pros to battle counterfeiting

13-Jan-2021 By Jenni Spinner

Fight the Fakes gathers manufacturers and other stakeholders to brainstorm on ways to combat falsified medicines and safeguard the world’s medicine supply.