Category Archives: Pharmaceuticals industry

Injectable HIV-prevention drug to be made in South Africa for the first time

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Indian drug company to make cheaper generic version of CAB-LA, potentially protecting millions of people in Africa from the virus

An affordable version of a groundbreaking HIV-prevention drug will be made in South Africa for the first time, potentially giving millions of people at risk of HIV infection in Africa access to a two-monthly jab that can almost eliminate their chances of contracting the virus.

The Indian drug company Cipla confirmed that a generic version of the prophylaxis, long-acting cabotegravir (CAB-LA), would be manufactured at its plants in Benoni, near Johannesburg, or Durban.

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Indian study reveals about 3% of drugs ‘substandard’ amid official crackdown

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In wake of children’s cough syrup scandal, an expert says regulatory system is ‘grossly understaffed and underfunctional’

About 3% of drugs routinely taken by Indians for ailments such as hypertension, bacterial infections and allergies are “substandard”, according to a study of samples taken from factories by government inspectors.

Officials have been carrying out random checks on factories after a scandal over Indian-made cough syrups linked to the deaths of children, mostly in countries in Africa.

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UK and Europe are falling behind US and China in biotech, says AstraZeneca boss

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Pascal Soriot says decline in startups across Europe differs markedly from ‘explosion’ of firms and clinical trials in China

The boss of Britain’s biggest drugmaker has said that the UK and the rest of Europe are falling behind China and the US in the creation of biotech firms and clinical trials of new medicines.

Pascal Soriot, chief executive of AstraZeneca, said that while China had seen an “explosion of biotech companies”, and a “rapid expansion of clinical trials” that puts it ahead of the US, the UK and EU had posted declines.

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Two-for-one prescription changes to save Australian patients more than $1.6bn

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Changes to be included in budget will slash costs for GP visits and medicines but pharmacists likely to push back against new policy

Millions of Australians will be able to buy two months’ worth of medicine for the price of a single prescription, in a move that will slash out-of-pocket costs for GP visits and medicines.

The health minister, Mark Butler, announced the change on Wednesday, suggesting it will save patients more than $1.6bn over the next four years.

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AstraZeneca overtakes Pfizer as crunch week for UK pharma looms

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Driven by a revamped drug portfolio, AstraZeneca is expected to report revenues of $10.7bn in its latest quarterly results

Nearly a decade after AstraZeneca fended off a hostile takeover approach from US rival Pfizer, the British drug firm has overtaken the Viagra maker in terms of market value, marking a significant moment in its turnaround – and for UK plc.

In a week when AstraZeneca and Britain’s second-biggest pharma firm GSK release their latest quarterly results and the main industry body, the Association of the British Pharmaceutical Industry holds its annual conference, all eyes will be on what pharma executives say about the UK as a place to operate and invest in.

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Novartis scraps cholesterol drug trial in blow to UK life sciences ambitions

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Swiss firm’s withdrawal from Leqvio trial with NHS dents government plans to attract post-Brexit research and investment

The Swiss pharmaceutical firm Novartis has ditched plans for a large clinical trial in the UK, in a further blow to the government’s efforts to make Britain an attractive place for research and investment after Brexit.

The company decided to scrap the Orion-17 trial of its cholesterol-lowering drug Leqvio, involving 40,000 patients in partnership with NHS England.

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Drugmaker Eli Lilly says it will cut insulin prices by 70%

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Move comes amid criticism of healthcare companies over rising costs of insulin, as CEO says cuts ‘should be the new standard’

Eli Lilly will cut list prices by 70% for its most commonly prescribed forms of insulin, Humalog and Humulin, beginning from the fourth quarter of this year, the drugmaker said on Wednesday.

The move comes amid criticism of healthcare companies by US lawmakers over rising costs of insulin, with Joe Biden’s signature Inflation Reduction Act including a $35 cap on insulin for those enrolled in Medicare health insurance plans.

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US moves to simplify Covid vaccines into yearly dose to target variants

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The FDA asked its scientific advisers on Thursday to help chalk out plan to move to a flu shot-like schedule for coronavirus

The US is poised to make Covid-19 vaccinations more like a yearly flu shot, a major shift in strategy despite a long list of questions about how to best protect against a still rapidly mutating virus.

The Food and Drug Administration asked its scientific advisers on Thursday to help lay the groundwork for switching to once-a-year boosters for most Americans – and how and when to periodically update the shots’ recipe.

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FDA under fire over approval of Alzheimer’s drug Aduhelm

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House of Representatives’ report details ‘corporate greed’ and ‘atypical review process’ preceding agency’s approval of Biogen’s drug

US drug regulators failed to follow their own guidance and practices when they approved the controversial Alzheimer’s drug Aduhelm, a congressional report said on Thursday.

The US food and drug administration’s (FDA) process of approval, it said, had been “rife with irregularities”, and the FDA’s interactions with maker Biogen had been “atypical”.

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Gene therapy at $3.5m a dose approved for US adults with hemophilia B

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Hemgenix frees patients from repeated treatments but initial cost makes it most expensive medicine in the world

US drug regulators have approved a one-off gene-therapy treatment for adults with the genetic blood disorder hemophilia B that frees patients from repeated treatments but costs $3.5m a dose, making it the most expensive medicine in the world.

The US Food and Drug Administration (FDA) approved CSL Behring’s hemophilia B gene therapy Hemgenix on Tuesday. It cuts the number of bleeding events expected over the course of a year by over half, a study found, and reduces 94% of patients from the need for regular infusions to control the condition.

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Pill to prevent pre-eclampsia gets UK fast track for development

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Exclusive: MHRA grants innovation passport to drug that could prevent women from developing condition

A new pill that could prevent pre-eclampsia has become the first pregnancy drug to be fast-tracked for development by the UK’s drug regulator.

Scientists at MirZyme Therapeutics, a biopharmaceutical company, believe they have developed a drug that when given to women from 20 weeks of pregnancy could stop them developing the condition.

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Indonesia bans sale of syrup medicines after at least 99 child deaths

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Country investigating 206 cases of kidney injury that could be linked to ingredients in liquid medicines

Indonesia has banned the sale of all syrup medicines as it investigates the deaths this year of nearly 100 children, warning that the liquids may contain ingredients linked to fatal kidney injuries.

The move comes just weeks after the World Health Organization issued an alert over four Indian-made cough syrups that it said were potentially linked with acute kidney injuries and the deaths of 70 children in the Gambia.

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Campaigners celebrate as V&A severs Sackler links over opioids cash

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London museum bows to years of pressure and removes signs acknowledging the family behind the OxyContin crisis

Campaigners calling for the name Sackler to be dropped from cultural landmarks are celebrating this weekend. Their smiles mark five years of demonstrations and dramatic stunts as another major arts institution – London’s Victoria and Albert Museum – takes down signs acknowledging the financial contribution from this wealthy family.

The museum is dropping it controversial ties with the Sackler family, descendants of US makers of addictive opioid prescription drugs. It’s a victory for the campaign group Sackler P.A.I.N, which staged a dramatic public protest at the gallery in November 2019. The group, led by American artist Nan Goldin, argued that donations from the family that founded now-bankrupt Purdue Pharma, maker of the painkiller OxyContin, were a moral stain on cultural institutions that accepted them.

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Limits on paracetamol purchases could reduce injury and death from overdoses, expert panel says

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TGA report recommends reduced packet sizes and restricting over-the-counter sales of the drug to people 18 and over

The size of paracetamol packets sold in supermarkets could be reduced and limits introduced on the number of boxes that can be bought, in a bid to reduce injury and death from intentional overdoses.

The recommendations are contained in an independent expert report published by Australia’s drugs regulator, the Therapeutic Goods Administration. The report found rates of intentional paracetamol overdose were highest among adolescents and young adults, and more common among women and girls.

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Artists must expose corruption, urges director of documentary on opioid crisis

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The story of Nan Goldin, a photographer who campaigned against the Sackler family’s Purdue Pharma, premieres at the Venice Film Festival

A documentary about artist Nan Goldin’s fight to hold members of the Sackler family to account for the opioid crisis is “a challenge to other artists” to use their power to expose corruption, its director Laura Poitras has said.

The maker of lauded films including Risk (about Wikileaks) and Citizenfour (about Edward Snowden) was premiering All the Beauty and the Bloodshed in competition at the Venice film festival on Saturday.

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Cancer researchers unable to access clinical trial data for top-selling drugs, study finds

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Lack of transparency from pharmaceutical companies on anticancer medication has implications for health equity, Australian scientist says

Clinical trial data that saw some of the world’s most widely used cancer drugs approved by the US drugs regulator remains secret, despite a pharmaceutical industry commitment to transparency made in 2014.

The authors of a study published in the journal JAMA Oncology on Friday said the lack of transparency should be concerning to Australia.

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Distributors didn’t fuel opioid epidemic in West Virginia, judge rules

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Doctors’ ‘good faith’ prescribing decisions drove volume of painkillers shipped to pharmacies, says district judge David Faber

The US’s three largest pharmaceutical distributors were not responsible for fueling an opioid epidemic in a part of West Virginia, a federal judge ruled on Monday.

District judge David Faber rejected efforts by the city of Huntington and Cabell County to force McKesson, AmerisourceBergen and Cardinal Health to pay $2.5bn to address a drug crisis prompted by a flood of addictive pills in their region.

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Pfizer to offer all its drugs not-for-profit to 45 lower-income countries

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Company launches ‘healthier world’ accord in Davos and speaks to other pharma firms about similar steps

Pfizer has announced it is to supply all its current and future patent-protected medicines and vaccines on a not-for-profit basis to 45 lower-income countries and is talking to other big drugmakers about similar steps.

Announcing an “accord for a healthier world” at the World Economic Forum (WEF) annual meeting in Davos, the New York-based pharma firm pledged to provide all its products that are available in the US and Europe on a cost basis to 1.2 billion people in all 27 low-income countries such as Afghanistan and Ethiopia, plus 18 lower-middle-income countries including Ghana.

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AstraZeneca reviews diversity in trials to ensure drugs work for all

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Firm aims to apply ‘equity lens’ across clinical tests to ensure diverse population groups take part

The pharmaceutical giant AstraZeneca is conducting a major review of diversity across its trials in an attempt to ensure its medicines work for all population groups, although it has admitted that including pregnant women is a particular challenge.

The head of oncology at Britain’s biggest drugmaker, David Fredrickson told the Guardian that the firm was among those leading efforts to improve participation of people of colour and other under-represented groups in clinical trials.

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Valneva approved to be UK’s sixth Covid vaccine

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Medicines regulator says it is first in world to approve Valneva product

A Covid-19 vaccine developed by the French pharmaceutical company Valneva has been given regulatory approval by the Medicines and Healthcare products Regulatory Agency, bringing the total number of jabs approved for use in the UK to six.

As the Covid pandemic swept the world, scientists began developing vaccines against it, with the Pfizer/BioNTech jab being the first in the UK to be authorised for emergency use by the MHRA in 2020. Since then the MHRA has approved the Moderna, Oxford/AstraZeneca, Janssen and Novavax vaccines, although, according to NHS England, Janssen and Novavax are not currently available.

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