Press review

 - 

GSK begins large scale pilot for children's malaria vaccine in Malawi

LONDON, 26 Apr (APM) - A large-scale pilot of a GlaxoSmithKline vaccine that could prevent some of the 250,000 child deaths each year from malaria has begun in Malawi after successful clinical trials, the Financial Times reported on Wednesday.
The vaccine - called RTS,S - acts against the deadliest malaria parasite and has been in development by GSK for more than three decades. According to the World Health Organization (WHO), it is the first vaccine to demonstrate it can significantly reduce cases of malaria in children.
In clinical trials, the vaccine was found to prevent about four in 10 cases of malaria, as well as reducing malarial anaemia - the reason most children die from the disease - by 60%. The vaccine does not claim full protection from malaria, however, and must be used alongside existing prevention methods.
The WHO estimates that there were 219 million cases of malaria and 435,000 deaths in 2017. Some 93% of deaths from malaria are in Africa. In some low-income countries, the infectious disease is the sixth-biggest cause of death.
The Malawi pilot, together with similar operations in Kenya and Ghana, will vaccinate about 360,000 children per year over five years. If successful, the WHO could recommend its use worldwide, the FT said.

Cancer drugs not reaching the patients who need them - report

One in six people diagnosed with cancer have faced problems getting the drugs recommended by their doctors, according to a report by the Institute of Cancer Research (ICR) in London, the Daily Mail reported on Thursday.
NHS rationing, red tape and hold-ups mean 16% of patients have either faced delays getting cancer treatments or been denied them altogether, polling by the organisation has found.
Cancer specialists - who on Thursday published a 10-point manifesto calling for action to improve drugs access - say the sky-high price of modern treatments and inflexibility of NHS watchdog NICE are at the heart of the problem.
Professor Paul Workman, chief executive of the ICR, said: "We will only make step-change advances against cancer by giving patients access to genuinely innovative new drugs, which can attack cancer in brand new ways or as part of innovative combinations to overcome the challenge of drug resistance.
"We need drug regulators and NICE to be faster and more flexible in their assessment of evidence, especially for the most innovative treatments.
"And it's crucial to address the extremely high prices of cancer drugs, which researchers and patients agree are the biggest barrier to getting them to patients."

Liquid biopsy could match cancer patients to personalised medicine trials

The Times on Tuesday covered study results that suggest a liquid biopsy blood test could match cancer patients to trials of personalised medicines.
A third of patients given experimental treatments in this way saw their tumours shrink in "very promising" early results, said the paper.
The study was carried out by the Cancer Research UK Manchester Institute, which showed that it was possible to use a liquid biopsy looking at 641 genes to see if patients’ tumours had a DNA mutation that could be targeted by an experimental drug.
In a study of 100 patients with tumours, including breast, bowel, prostate, lung and skin, 70 were found to have at least one mutation, with 41 potentially targetable by personalised drugs. Of these, 11 patients were able to be matched quickly to a clinical trial.

UK accused of ignoring expert warning in opioid battle

The Sunday Times accused the UK government of ignoring a warning from expert advisers about the influence of drug giants on its inquiry into the abuse of prescription medicine.
Public Health England (PHE) is investigating the problem of NHS patients becoming dependent on medicines from GPs, including opioids, anti-anxiety drugs and antidepressants.
A year ago, PHE was warned after repeatedly using the euphemistic phrase "discontinuation syndrome" to describe difficulties when patients stop taking the medicines, documents reveal. This phrase, which has been linked to Eli Lilly, has been criticised for downplaying the incidence, severity and duration of the side effects of coming off these drugs.
PHE pledged to review its use of the term, according to the minutes of an inquiry meeting in April 2018. However, the inquiry is still using the controversial phrase a year after the warning and it also appears on the government’s website.

Serious Fraud Office drops GSK case

The UK's Serious Fraud Office spent £7.5 million on its corruption investigation into GlaxoSmithKline before dropping the case, said The Times at the weekend.
It abandoned the five-year inquiry into alleged bribery at the pharma company in February after Lisa Osofsky, its new boss, reviewed the agency’s caseload.

Silence Therapeutics' 'zigzag' path

Shares in biotech Silence Therapeutics fell by £2.50 to 58 pence in 18 months, the FT said at the weekend.
During this time the company also lost three chairmen and revamped its management team.
The FT spoke to CEO David Horn Solomon who said the company's trajectory has "been a bit of a zigzag", adding that he expects to announce a new chairman shortly.

Biotech success in antibiotic market

The FT at the weekend carried a feature by Jeremy Farrar, a director of the Wellcome Trust, on Achaogen, a biotech working in the antibiotics market.
The article said that decades of disinvestment have meant there are "perilously few companies" active in the field and those that remain are dependent on support from philanthropic or public funders.
Achaogen is one of a number of new biotechs to receive funding in this way that are now driving antibiotic innovation, with the FT saying the company defied the odds to gain U.S. approval last year for plazomicin for treating complex urinary tract infections caused by drug-resistant bacteria. The FT described Achaogen as a "leading example" of what can be achieved by a start-up working in partnership with government and philanthropic funders.

AZN's Soriot on Pfizer's attempted deal and R&D

The FT on Wednesday carried an interview with AstraZeneca's CEO Pascal Soriot (APMHE 62754) during which he discussed Pfizer's attempt to buy the company five years ago.
The paper said that much of Soriot's successful defence against the acquisition rested on a personal appeal to investors and AZN's board to trust that he could reinvigorated the company's R&D.
The value of AZN's stock surpassed Pfizer's offer of £55 per share last autumn, giving Soriot some vindication, said the FT.
Soriot also commented on a restructure of the company's R&D process announced earlier this year to create separate units focused on oncology and biopharmaceuticals. He said the existing R&D model had served the company very well for a number of years but "as you grow bigger and more successful with more projects [the risk is] you revert…back to being governance-focused, process-driven, a bit bureaucratic, a bit risk averse, and then you start slowing down.
"So, you've got to act… because if you wait until you've slowed down to act, then you're behind the ball already."

Novartis increases outlook for 2019 after positive Q1

Novartis has upgraded its earnings outlook for 2019 after Q1 results exceeded forecasts, the FT said on Wednesday.
The Swiss pharma said sales grew to $11.11 billion, climbing 7% from the first quarter of 2018 (APMHE 62749).

FDA approves generic version of opioid overdose spray Narcan

The first generic version of the opioid overdose-reversing nasal spray, Narcan, has been approved by the U.S .Food and Drug Administration (FDA), the Daily Mail reported on Wednesday.
The paper said the approval for Teva's product comes after a nationwide push to make the drug more accessible in order to help combat the rise of overdose deaths in the U.S. opioid epidemic.
Narcan typically sells for $130 to $150 for a pack of two doses. Teva has not yet released its price-point, but generics typically run 80% to 85% cheaper than name brand drugs.

Genomics Medicine opens Dublin clinic to expand research

Genomics Medicine Ireland, a company aiming to build a genetic database for a large portion of the country’s population, has opened a new Dublin city centre office, The Times reported on Saturday.
GMI said that the new centre would facilitate the expansion of its Genofit research programme, which aims to study the potential genetic factors contributing to fitness and health. It would contribute to the goal of gathering the genetic information of about 400,000 Irish people.
The research may result in "the identification of specific genetic factors that protect an individual against the development of a particular health condition", the company said. It claimed that the study could lead to "targeted interventions" to improve people’s health in the future.

AstraZeneca enjoys third successive sales rise

AstraZeneca on Friday reported its third successive quarter of rising sales, on the back of robust sales of its new oncology drugs and a strong showing in emerging markets, especially China (APMHE 62780), the FT reported.
After returning to revenue growth in the third quarter of 2018, the UK pharma posted a 14% increase in product sales after stripping out currency fluctuations, to $5.46 billion.

BMS raises forecasts on strength of cancer, stroke drugs

The FT on Thursday said Bristol-Myers Squibb raised forecasts for the full year after it beat expectations on earnings and revenue in the first quarter, driven by soaring sales of its stroke prevention and cancer drugs. (APMHE 62770)
The U.S. pharma increased its 2019 guidance for GAAP (generally accepted accounting principles) earnings per share to between $3.84 and $3.94, and confirmed its non-GAAP guidance of earnings between $4.10 and $4.20 per share.
BMS overcame opposition from shareholder activists Starboard Value and large shareholder Wellington Management to receive shareholder approval for its $90 billion acquisition of Celgene during the quarter.

Novartis upgrades 2019 guidance on 'strong' sales growth

The FT on Wednesday said Novartis upgraded its earnings outlook for 2019 after net sales and core operating income exceeded forecasts, as the drugmaker doubled down on its medicines business. (APMHE 62749)
The Swiss pharma said net sales grew to $11.11 billion, rising 7% at constant currencies in the first quarter of 2019 against the same period in 2018. The gain was driven in part by increased sales in its "innovative medicines" division, which includes Cosentyx and Entresto.
A Bloomberg poll of analysts had forecast net sales of $10.84 billion for the period, the paper said. 
Net income grew 4% on a constant currency basis, a figure Novartis said had been affected by an impairment charge and lower divestment gains. 

AbbVie raises forecast despite pressure on Humira

AbbVie beat expectations on earnings and raised its forecasts despite suffering a 28% drop in international sales of Humira, its blockbuster drug for inflammatory diseases, due to competition outside the U.S., the FT reported on Thursday. (APMHE 62772)
The Illinois-based pharmaceutical company guided to adjusted earnings per share for the full year of between $8.73 to $8.83, from a range of $8.65 to $8.75, it said.
nh/tm/nm

[TM0PQEQB1]

TRY APM HEALTH EUROPE AND GET ACCESS TO THE FULL CONTENT

Interviews with KOLs/senior executives amongst the Regulators, Payers, Health, Medical & Pharmaceutical organisations

Events coverage with a unique focus on Market Access & sustainability of healthcare systems

6 European bureaus : Berlin, Brussels, London, Madrid, Milan & Paris

Ask for a Free trial and get access to our last stories

Request a trial to assess coverage that includes:
  • Health Care
  • Market Access
  • HTA – policies & practices
  • European medicine regulations
  • Drug safety issues
  • Pricing & Reimbursement
  • International medicines agencies

If you are a Payer, Pharmaceutical or Consulting professional our premium data will keep you informed on the regulatory, pricing, market access and cost-effectiveness issues that impact all stakeholders.

REQUEST

an initial 10 day temporary access of APM Health Europe.