Hello and Happy New Year from team ramarketing. After the festive break we’re back with a roundup of the pharma and biotech news you need to know.
This week we look at how the US Government shutdown is impacting the FDA, India’s efforts to encourage local drug production, the boom in UK biotech investment and how pharma is preparing for Brexit.
US FDA to carry on user fee funded ops during shutdown
The US FDA says it will continue to carry out user-fee funded activities for prescription drugs, generics, biosimilars and medical devices during the ongoing US Government shutdown.
The drug regulator issued the clarification on Friday, explaining it will continue oversight of the pharma industry to the “extent permitted by the law.”
The partial shutdown began on December 22 after President Donald Trump refused to sign a 2019 budget proposal in a spat centred on his efforts to secure funding for a border wall between the US and Mexico.
As a result, some 800,000 federal employees are either working without pay or have been told to go home and a number of Government agencies have ceased non-vital activities.
The FDA said “mission critical” activities like monitoring food-borne illness and the flu, supporting recalls and screening imported food and drugs and addressing critical public health issues will continue.
The agency also said mission critical surveillance for significant safety concerns with medical devices and other medical products will continue.
…US drug approval soar in 2018
In related news, the CDER reported that 59 new drugs were approved by FDA reviewers in 2018. Pharmaceuticalcommerce looked at the specific products in the context of pharmaceutical sector R&D investments.
India hikes local component reqs. for drugs used in Gov programmes
The Indian Government has mandated that 75% of the components of drugs bought by public procurement programmes must be made locally.
The Department of Pharmaceuticals imposed the rule last week also outlining a plan to increase the requirement to 90% by 2023.
It said, “The Department of Pharmaceuticals (DoP) hereby notifies that purchase preference shall be provided by all Government Procuring entities to local suppliers of Pharmaceutical Formulations in various dosage forms.”
UK biotech investment soars in 2018
Investment in UK biotechnology has increased despite concerns about withdrawal from the EU.
According to a Guardian report, UK biotechnology firms received £1.6bn in funding during the first eight months of last year compared with £1.2bn in the equivalent period in 2017.
The article cites Adaptimmune, Cell Medica, Autolus and Freeline Therapeutics as examples of firms that have garnered support. It also highlights several Government-backed development and manufacturing centres as a factor.
Also in the news
UK drug companies helping the Government prepare for Brexit have signed non-disclosure agreements according to various reports. The orders prevent the companies involved from sharing details of stockpiling and supply chain planning efforts.
A number of drug companies have increased prices in the US according to the Wall Street Journal. In its coverage, First Word Pharma points out that Allergan and GSK have started charging more for their products.
The Motley Fool has raised questions about B-MS’ plan to buy Celgene citing the $74bn price tag and patent concerns about the latter’s lead product Revlimid.
High CRA turnover rate continues to be a problem for the contract research sector according to a report by BDO.
GlobalData Healthcare looked at drug manufacturing in China.