Press review

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NHS to stop funding thyroid drug after price increase

LONDON, Nov 3 (APM) - The National Health Service (NHS) in England is planning to stop prescribing liothyronine after the only supplier increased the price of a tablet from 16 pence to 9.22 pounds, The Times said on Tuesday.
The paper said price rises were brought in by Concordia International and a company that it bought. Concordia has previously been exposed by an investigation in The Times for imposing big price increases for drugs.
The NHS says that the drug, a synthetic version of the hormone T3 which is used to treat patients with underactive thyroids, is “clinically effective but... has been subject to excessive price inflation”. Some health trusts have already stopped funding liothyronine, despite the fact that a consultation on the increases has only just ended.

Andrew Witty to oversee fast-track scheme for ‘breakthrough’ drugs

The UK has announced a fast-track scheme for breakthrough drugs to reach National Health Service (NHS) patients up to four years earlier than at present, it is being reported on Friday. (APMHE 55447)
Both The Times and the Daily Telegraph cover the launch of the Accelerated Access Pathway initiative, which will be overseen by former GlaxoSmithKline chief executive Sir Andrew Witty.
Promising drugs will receive “breakthrough” designation, unlocking a package of public sector support from clinical development through to faster commercial deals with the NHS.
The government also announced 86 million pounds of funding to be directed towards helping SMEs adopt digital platforms and encourage the uptake of medical technologies.

Companies threaten legal action against NHS for prescribing Avastin in unlicensed eye indication

Bayer and Novartis are threatening legal action to prevent NHS patients with wet age-related macular degeneration (AMD) in England being offered Roche’s Avastin (bevacizumab) instead of Lucentis (ranibizumab), it was widely reported on Wednesday.
Twelve NHS clinical commissioning groups (CCGs) in the north east of England say they can save money by using the cheaper Avastin, arguing that is as effective as Lucentis despite not being authorised to treat the eye condition (APMHE 55413).
The Times said that England’s drug guidance body NICE has judged that Avastin is just as safe and effective as the other drugs, but said it cannot recommend an unlicensed treatment.
The story was also picked by the Guardian, the Daily Telegraph and the Daily Mail.

Company breaches of UK pharma code rise by 63%

Breaches by pharmaceuticals companies of the UK prescription medicines code have risen sharply, the Times said on Monday.
The paper said the number of complaints received by the PMCPA, which oversees the code, rose by 41% to 76 last year, according to its annual report. This led to 100 cases, a 52% increase for the authority, which found 57 breaches of the code that governs standards for the promotion of medicines, a 63% rise from 2015 (APMHE 55402).

Accelerated approval for AZN’s Calquence for blood cancer in U.S.

The Times on Wednesday said the U.S. Food and Drug Administration has granted accelerated approval for AstraZeneca’s Calquence (acalabrutinib), a treatment for adults with a rare type of blood cancer called mantle cell lymphoma, who have received at least one prior therapy (APMHE 55404).
The company’s CEO Pascal Soriot called the approval, which triggers a $1.5 billion payment to shareholders in the biotechnology company, a “landmark moment” for AZN.

FDA committee backs Indivior’s drug for opioid addiction

An advisory committee at the FDA voted 18 to 1 to recommend approval of Indivior’s RBP-6000, a new treatment for opioid addiction, the FT said on Wednesday.
The recommendation is non-binding, but will be considered by the FDA when it makes its final decision on the use of the drug (APMHE 55412).
The news comes weeks after Indivior warned that a U.S. court ruling had “significantly increased” the risk of new competitors to its Suboxone Film treatment, which could see it lose up to 80% of its market share “within a matter of months”.

GSK receives FDA boost for new cancer treatment

The FT on Thursday reported that GlaxoSmithKline has received approval to fast-track the development of a potentially “transformational” blood cancer treatment, as it doubles down on its search for new blockbuster drugs to offset declining sales of older products.
The FDA granted breakthrough therapy designation for the new drug, currently named only GSK2857916. The designation means the regulator will work with GSK to speed up the development and review of the treatment, and suggests the FDA sees potential for a “substantial improvement” compared to existing therapies.
The product has also been granted a similar status by European authorities. Axel Hoos, GSK senior vice president for Oncology R&D, said the company “plans to rapidly advance clinical trials with this promising therapy”, which early trials suggest has “transformational potential”. (APMHE 55442)

Merck & Co withdraws bid to extend Keytruda’s lung cancer indication in Europe

The FT at the weekend said that Merck & Co has withdrawn an application with the European medicines regulator that would have allowed its Keytruda immunotherapy to be used in combination with chemotherapy (APMHE 55367).
The combination of the drug with chemotherapy has already been approved by the FDA for some lung cancer patients, but the European Medicines Agency’s CHMP in Europe was apparently not convinced.

GSK chief scientist to leave for advisory role in UK government

The FT on Friday says GlaxoSmithKline’s chief scientist is set to leave for a senior job in the UK government, according to two people briefed on the situation.
Patrick Vallance, president of research and development at the UK company for almost six years and a member of its board since January, will become the UK’s chief scientific adviser, providing counsel to the prime minister and cabinet. (APMHE 55446)

Mylan shares down after exec named in lawsuit

Shares in Mylan were down 6.1% after 45 state attorneys general targeted one of the company’s top executives as they moved to expand a lawsuit stemming from a years-long probe into alleged price collusion by generic drugmakers, the FT said on Tuesday.
The paper said the attorney general for Connecticut announced he is seeking to file an expanded complaint against generic drugmakers that names Rajiv Malik, president and executive director of Mylan, as a defendant. (APMHE 55408)

Sanofi confirms 2017 outlook despite struggling diabetes business

Sanofi has confirmed its full-year outlook despite cutting sales guidance for its struggling diabetes franchise, the FT said on Thursday.
Total sales at constant exchange rates rose 4.7% year-on-year to 9.05 billion euros during the three months to the end of September, below expectations of 9.33 billion euros in a Reuters poll, as diabetes and cardiovascular sales dragged (APMHE 55421).

Teva shares plunge after poor third quarter

Teva shares fell on Thursday after the Israeli company cut its full-year outlook and posted disappointing quarterly results amid a sharp downturn in its U.S. generics business, the FT said on Thursday (APMHE 55441).
The stock fell more than 14% to $12 after the company said a 1% rise in its revenues to $5.6bn was short of the average analyst estimate of $5.65bn, according to a Thomson Reuters survey.

Immunology treatments boost revenues at Shire

Shire delivered a solid increase on profits in the third quarter after better than expected sales of its immunology treatments offset the impact of manufacturing problems with one of its other drugs, the FT said at the weekend.
Revenues for the three months to September increased 7% year-on-year to $3.7 billion, including a slight boost from exchange rate movements.

AbbVie raises guidance after solid Q3

AbbVie posted adjusted earnings of $1.41 per share, around 3 cents ahead of expectations, while revenues of $6.96 billion were in line with consensus, the FT said at the weekend.
AbbVie raised its guidance for full-year adjusted earnings to between $5.53 and $5.55 per share versus its earlier range of $5.44 to $5.54.

Novartis to buy France’s Advanced Accelerator Applications

The FT on Monday said Novartis has announced a $3.9 billion deal to buy Advanced Accelerator Applications (AAA), a French company specialising in nuclear medicines used to treat tumours.
AAA makes radiopharmaceutical products which contain radioisotopes and are used clinically for both diagnosis and therapy of tumours. The company had sales of €109m in 2016. (APMHE 55365)

AZN takes stake in Mereo as part of deal to sell drug

AstraZeneca is taking a stake in Mereo Biopharma as part of a deal to sell the commercial rights to AZD9668, which is being developed as a treatment for a rare genetic disorder that causes lung and liver problems.
Mereo will pay for the licence through an initial cash payment of $3 million plus around 491,000 shares. Further cash and share payments may be made on completion of milestones such as new studies. (APMHE 55374)

Shanghai Fosun to buy Africa-focused Tridem

China-based Shanghai Fosun Pharmaceutical has agreed to buy Tridem, an Africa-focused French drug distributor, for up to €63 million euros ($73.1 million), the FT said on Monday.
The French company is the third-largest pharma distribution and promotion company in French-speaking Africa, according to the filing, with a sales network covering 21 countries and regions.

AI approach could do away with need for placebos in trials

The Sunday Times reported on Medidata, a company that has developed a machine-learning system that could overhaul the testing of experimental treatments by doing away with the need for placebos in clinical trials for new drugs.
Medidata’s system could tap into a backlog of existing data from related experiments, removing the need for a placebo control group in randomised clinical trials, the paper said.
“It will fundamentally change the way trials are run,” said Mike Capone, chief operating officer at Medidata. “In paediatric trials, they are already encouraged by the result.”

Disappointing results for AstraZeneca’s tralokinumab in asthma

The FT on Wednesday said AstraZeneca has announced “disappointing” trial results for a therapy it has been developing for severe asthma (APMHE 55410).
The group said in a stock exchange announcement that top-line trial outcomes for its tralokinumab antibody “did not achieve a statistically significant” outcome for patients with severe asthma.
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