Regulation & Policy

Bayer acquisition of Monsanto moves closer to completion

Subject to approval from US regulators, Bayer AG hopes to conclude its $66 billion takeover of Monsanto Co in the second quarter. The transaction would be the third merger of its kind in just under 12 months, illustrating the global consolidation of the agrochemical and seed businesses. This is being enabled by biotechnology, which makes it possible for crops to be engineered to resist insects, and digital technology which gives farmers new tools for managing their fields.

Full text available to subscribers only. Click here for information on subscribing to MedNous.

Location

Germany

Meeting Report – Joint HTA in the European Union

If everything goes according to plan, member states of the European Union will in future use a common methodology to decide whether a new medicine or medical device is clinically effective, relative to certain benchmarks, and therefore be considered for reimbursement. This is the scenario envisioned by the European Commission under a proposed Regulation on Health Technology Assessment, which was unveiled earlier this year.

Full text available to subscribers only. Click here for information on subscribing to MedNous.

Location

Netherlands

New Alzheimer’s guidance

With new evidence showing that the biological changes associated with Alzheimer’s disease start earlier than expected, the European Medicines Agency has revised its guideline for companies developing drugs for the disease.

Full text available to subscribers only. Click here for information on subscribing to MedNous.

Location

United Kingdom

FDA focuses on neurology

Citing the urgent need for new drugs to treat neurological diseases, the US Food and Drug Administration has shaken up its review teams to encourage experts to work across disciplines and identify new opportunities for treatment.

Full text available to subscribers only. Click here for information on subscribing to MedNous.

Location

United States

Meeting Report: When clinical trials become too complex

After one volunteer died and four others were seriously injured during a clinical study in France in 2016, the European Medicines Agency revised its rules for first-in-human studies to tighten the requirements for the dosing of experimental drugs in humans. Introducing the changes in 2017, the agency said that clinical trial protocols are now more complex than ever before and sponsors will need to work harder to exercise oversight.

Full text available to subscribers only. Click here for information on subscribing to MedNous.

Location

Belgium

New indication for AZ’s checkpoint antibody

AstraZeneca Plc has won a new indication for its checkpoint antibody Imfinzi (durvalumab) from the US Food and Drug Administration to reduce the risk of non-small cell lung cancer progressing. Imfinzi targets the programmed death ligand-1 (PD-L1).

Full text available to subscribers only. Click here for information on subscribing to MedNous.

Location

United States

FDA approves cancer drug using novel endpoint

The US Food and Drug Administration has used a novel endpoint to approve a new drug for prostate cancer. Measuring metastasis-free survival, the agency decided that the Janssen Pharmaceutical drug Erleada (apalutamide) is effective.

Full text available to subscribers only. Click here for information on subscribing to MedNous.

Location

United States

Commentary: Can US healthcare be fixed?

After Amazon, Berkshire Hathaway Inc and JP Morgan Chase & Co announced on 30 January that they will take steps to reduce the rising cost of US health insurance, shares of health insurance companies and pharmacies declined.

Location

United States

Common rules for HTA

A decades’ long discussion in the EU about how to establish common rules for assessing the value of new medicines has come to a conclusion with a proposal from the European Commission on 31 January to regulate health technology assessment (HTA).

Full text available to subscribers only. Click here for information on subscribing to MedNous.

Location

Belgium

Positive opinion for haemophilia drug

The European Medicines Agency is recommending approval of a new medicine for haemophilia A developed by Roche that is intended to prevent bleeding or reduce the frequency of bleeding episodes in patients who have developed resistance to existing medicines.

Full text available to subscribers only. Click here for information on subscribing to MedNous.

Location

Switzerland

Syndicate content