News

Lombard Medical to delist in London and pursue US IPO

Country
United Kingdom

Lombard Medical Technologies Plc is planning to delist its shares in London and make an initial public offering on the Nasdaq market in New York. The company said this will give it access to a larger pool of investors familiar with its market.

Switzerland’s Nextech leads US oncology financing

Country
Switzerland

Nextech Invest Ltd of Switzerland has led a $25 million Series B financing round for a young US biotech company that is developing kinase inhibitors for genomically-defined cancer subsets. Blueprint Medicines Corp is located in Cambridge, Mass.

Ibrutinib trial stopped early

Country
United States

A Phase 3 study of an experimental treatment for chronic lymphocytic leukaemia and small lymphocytic lymphoma has been stopped early on efficacy grounds. The treatment, Imbruvica (ibrutinib) has been developed by Janssen Research & Development LLC.

Complete response letter for Lemtrada

Country
France

The US Food and Drug Administration has issued a complete response letter (CRL) to Sanofi SA saying it can’t approve the company’s supplemental Biologics License Application for Lemtrada (alemtuzumab) for relapsing multiple sclerosis.

Genetic variants affect cognition

Country
Belgium

A group of international researchers has described how abnormalities in the human genome affect cognition, explaining why some people develop neurological diseases such as schizophrenia and autism, and others do not. The findings were reported online in the journal Nature on 18 December.

Agreement on EU Clinical Trials Regulation

Country
Belgium

Europe’s political leaders have reached an agreement on a new set of rules for conducting clinical trials in the EU. A key feature of the new legislation will be the introduction of a single authorisation procedure for all trials instead of multiple procedures at present.

EMA recommends new tuberculosis drug

Country
United Kingdom

The European Medicines Agency is recommending that Sirturo (bedaquiline) be granted a conditional market authorisation for pulmonary multidrug-resistant tuberculosis as part of a combination therapy. The new drug has been developed by Janssen Therapeutics.

AZ to take full control of diabetes assets

Country
United Kingdom

AstraZeneca Plc is to take full control of a portfolio of diabetes assets being managed jointly with Bristol-Myers Squibb (BMS) in order to strengthen its position in the market. The upfront payment to BMS is $2.7 billion with potential milestones of $1.4 billion.

Bayer in agreed takeover bid for Algeta

Country
Norway

The board of Algeta ASA is recommending that shareholders agree to a takeover offer from Bayer that values the company at NOK 362 ($58.7 per share) for a total of $2.9 billion. Bayer is Algeta’s partner for Xofigo, a recently approved radiopharmaceutical.

FDA approves Anoro Ellipta for COPD

Country
United States

The US Food and Drug Administration has approved Anoro Ellipta, a new medicine for chronic obstructive pulmonary disease (COPD) developed by GlaxoSmithKline Plc. It is the second COPD medicine from GSK to receive US approval this year.