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Published:

BENPEN benzylpenicillin (as sodium) 1.2g powder for injection vial (benzylpenicillin sodium)
Published: 6 Dec 2019 | 2:09 UTC

Manufacturing

PRIORIX-TETRA vaccine 0.5mL powder for injection vial with diluent syringe (Rubella virus)
Published: 6 Dec 2019 | 2:09 UTC

Manufacturing

SYNACTHEN DEPOT tetracosactide (tetracosactrin) zinc complex 1mg/1m L injection ampoule (tetracosactide (tetracosactrin))
Published: 6 Dec 2019 | 2:09 UTC

Manufacturing

AVSARTAN HCT 150/12.5 irbesartan 150 mg and hydrochlorothiazide 12.5 mg tablets blister pack (irbesartan)
Published: 6 Dec 2019 | 2:09 UTC

Unexpected Increase in Demand

VACLOVIR 500 valaciclovir (as hydrochloride) 500 mg tablet bottle pack (valaciclovir hydrochloride)
Published: 6 Dec 2019 | 2:09 UTC

Manufacturing

METFORMIN ARW 850 metformin hydrochloride 850 mg tablet blister pack (metformin hydrochloride)
Published: 6 Dec 2019 | 2:09 UTC

Other

AVSARTAN HCT 300/12.5 irbesartan 300 mg and hydrochlorothiazide 12.5 mg tablets blister pack (hydrochlorothiazide)
Published: 6 Dec 2019 | 2:09 UTC

Unexpected Increase in Demand

FLUTAMIN flutamide 250mg tablet blister pack (flutamide)
Published: 6 Dec 2019 | 2:09 UTC

Manufacturing

IRBESARTAN/HCT SANDOZ  300/12.5 irbesartan 300mg / hydrochlorothiazide 12.5mg film-coated tablet blister pack (hydrochlorothiazide)
Published: 6 Dec 2019 | 2:09 UTC

Product Recall

FDA Approves First Generics of Gilenya
Published: 5 Dec 2019 | 22:12 UTC

December 05, 2019 -- The U.S. Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients. “Approving safe...

Biogen divulges more data on Alzheimer’s trials
Published: 5 Dec 2019 | 19:14 UTC

Biotech’s shares fluctuate as it tries to win over sceptics of aducanumab

Annual Reported Measles Incidence Dropped From 2000 to 2018
Published: 5 Dec 2019 | 19:00 UTC

THURSDAY, Dec. 5, 2019 -- The annual reported measles incidence decreased from 2000 to 2018, but the number of cases increased from 2016 to 2018, according to research published in the Dec. 6 issue of the U.S. Centers for Disease Control and...

More Than 100 E. Coli Illnesses Now Linked to Romaine Lettuce
Published: 5 Dec 2019 | 19:00 UTC

THURSDAY, Dec. 5, 2019 -- Federal health officials are currently investigating a multistate outbreak of Escherichia coli infection linked to romaine lettuce thought to be grown in Salinas, California. Case numbers have risen from 67 reported a week...

Seven Deaths in California From Infections Tied to Black Tar Heroin
Published: 5 Dec 2019 | 19:00 UTC

THURSDAY, Dec. 5, 2019 -- Infections linked to injections of black tar heroin have killed seven people in San Diego County in the past two months, health officials said Wednesday. Between Oct. 2 and Nov. 24, nine adults, aged 19 to 57 years, were...

Evidence Uncertain Whether Interventions Prevent Falls in MS
Published: 5 Dec 2019 | 19:00 UTC

THURSDAY, Dec. 5, 2019 -- There is uncertainty regarding the effect of exercise and other interventions on the prevention of falls in patients with multiple sclerosis (MS), according to a review published online Nov. 28 in the Cochrane Database of...

Daily Cannabis Use Tied to Lower Illicit Opioid Use for Chronic Pain
Published: 5 Dec 2019 | 19:00 UTC

THURSDAY, Dec. 5, 2019 -- Individuals with chronic pain who use daily cannabis have lower odds of using illicit opioids, according to a Canadian study published online Nov. 19 in PLOS Medicine. Stephanie Lake, from University of British Columbia in...

Early-Onset CVD Rate Up for Children of Moms With Diabetes
Published: 5 Dec 2019 | 12:00 UTC

THURSDAY, Dec. 5, 2019 -- Children of mothers with diabetes have increased rates of early-onset cardiovascular disease (CVD), according to a study published online Dec. 4 in The BMJ. Yongfu Yu, Ph.D., from Aarhus University Hospital in Denmark, and...

RSNA: Brachytherapy Treats Skin Cancer in Elderly Patients
Published: 5 Dec 2019 | 12:00 UTC

THURSDAY, Dec. 5, 2019 -- Excellent local control and cosmetic outcomes are observed in elderly patients receiving high dose-rate brachytherapy (HDRBT) for early-stage nonmelanoma skin cancer of the head and neck region, according to a study...

Obstructive Sleep Apnea May Be Underdiagnosed in Women
Published: 5 Dec 2019 | 12:00 UTC

THURSDAY, Dec. 5, 2019 -- Men and women experience obstructive sleep apnea (OSA) during REM sleep at similar rates, according to a study published online Nov. 5 in SLEEP. Christine H.J. Won, M.D., from the Yale University School of Medicine in New...

EpiPen Jr
Published: 5 Dec 2019 | 7:00 UTC

Update on shortage

EpiPen Jr
Published: 5 Dec 2019 | 7:00 UTC

Update on shortage

Kulchaya Sheaya Lender capsules
Published: 5 Dec 2019 | 6:30 UTC

Kulchaya Sheaya Lender capsules pose a serious risk to your health and should not be taken

Kulchaya Sheaya Lender capsules
Published: 5 Dec 2019 | 6:30 UTC

Kulchaya Sheaya Lender capsules pose a serious risk to your health and should not be taken

Prescription medicines: new or extended uses, or new combinations of registered medicines
Published: 5 Dec 2019 | 5:30 UTC

8 medicine registrations added

Prescription medicines: registration of new generic medicines and biosimilar medicines
Published: 5 Dec 2019 | 5:30 UTC

4 medicine registrations added

Prescription medicines: registration of new chemical entities in Australia
Published: 5 Dec 2019 | 5:30 UTC

7 medicine registrations added

AusPAR: Influenza virus haemagglutinin
Published: 5 Dec 2019 | 4:45 UTC

Australian Public Assessment Report for Influenza virus haemagglutinin

Cymerus™ MSCs Effective in Preclinical Model of Sepsis
Published: 5 Dec 2019 | 0:00 UTC

Australian stem cell and regenerative medicine company, Cynata Therapeutics Limited (ASX: CYP), announced today that it has received positive efficacy data from preclinical studies of its Cymerus™ mesenchymal stem cells (MSCs) in a model of sepsis.

New Science Proves NZ Invented Extract Amarasate(TM) Reduces Hunger During Intermittent Fasting
Published: 5 Dec 2019 | 0:00 UTC

The science behind a breakthrough weight management extract invented in New Zealand has been proven in a study just-published in the scientific journal Nutrients.

NeuClone Announces Positive Results from Phase I Study of Herceptin® (Trastuzumab) Biosimilar Candidate
Published: 5 Dec 2019 | 0:00 UTC

NeuClone Pharmaceuticals Ltd (NeuClone), a clinical-stage biopharmaceutical company exclusively focused on developing high-quality biosimilar products, today announced that NeuCeptin, a biosimilar candidate of Herceptin® (trastuzumab), has successfully met all primary and secondary endpoints in a Phase I clinical trial.

Trump administration willing to drop USMCA pharma provisions
Published: 4 Dec 2019 | 7:09 UTC

Bid to win support from Democrats in deal seen as template for future negotiations

Comparable overseas bodies (COBs) for complementary medicines
Published: 4 Dec 2019 | 5:30 UTC

Information on comparable overseas bodies (COBs) for complementary medicines and listed OTC medicines

How pot stocks lost their highs
Published: 4 Dec 2019 | 4:00 UTC

Momentum has stalled in key markets such as New York, New Jersey and Connecticut

Hogan Lovells obtains dismissal of all remaining charges against former New York State Assemblyman
Published: 3 Dec 2019 | 0:00 UTC

2 December 2019 – A New York State Supreme Court judge in Manhattan has dismissed all remaining charges against former New York State Assemblyman Alec Brook-Krasny in a long-running...

QBiotics Announces First Patient Dosed in its Phase I/II Clinical Trial of Tigilanol Tiglate for Head and Neck Cancer
Published: 3 Dec 2019 | 0:00 UTC

QBiotics Group Limited (QGL), a life sciences company developing novel anticancer and wound healing pharmaceuticals, today announced that it has dosed its first patient in a Phase I/II clinical trial evaluating the optimal dosing and safety of its lead product, tigilanol tiglate, in patients with head and neck squamous cell carcinoma (HNSCC).

Outcomes: Changes to permissible ingredients - Low-negligible risk
Published: 2 Dec 2019 | 4:45 UTC

Outcomes of the consultation on low-negligible risk changes to listed medicine ingredient requirements have been published

Changes to the label warning statement requirements for menthol & methyl salicylate
Published: 2 Dec 2019 | 4:45 UTC

Some label warnings no longer required for medicines containing very low concentrations of menthol or methyl salicylate

Positive DARRT-1 Data in Late-Stage Prostate Cancer
Published: 2 Dec 2019 | 0:00 UTC

Noxopharm (ASX: NOX), an Australian drug development company, reports positive end-of-study data from its DARRT-1 Phase 1b trial.

Tories can’t be trusted to look after the NHS | Letters
Published: 1 Dec 2019 | 18:25 UTC

Only Labour’s policies can help solve the healthcare crisis, write 12 nurses. Plus, Dr Robert Oulton says NHS England’s latest reorganisation needs scrutiny, Fiona Henderson worries about price rises in a drug crucial for her husband, and Dr Andrew Hill offers ideas on how to protect the NHS in UK-US trade deals

We are frontline nurses who have faced the reality of government mismanagement over the disastrous years of coalition and Conservatism.

The outlandish and widely ridiculed promise from the Conservatives to recruit 50,000 more nurses (If voters think all politicians lie, then the Tories win, Journal, 30 November) would be unnecessary had they not spent the last nine years driving services and staff to breaking point. Tens of thousands of nursing posts remain vacant, impacting severely on the quality of care our patients deserve. Our colleagues face unprecedented levels of stress and distress in their work, with little support or insight from government.

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There’s a simple way to protect the NHS from US trade negotiators | Emily Jones
Published: 1 Dec 2019 | 14:45 UTC

Pass a law stating the health service is not on the table – this would allow UK negotiators to declare the whole area off limits

No wonder there is alarm when we hear the NHS is on the negotiating table in UK-US talks. In the US, citizens struggle to afford their prescriptions, and medical bills are so high that they are a leading cause of bankruptcy. The US spends more per person on medicines than anywhere else in the world.

The US pharmaceutical industry is large and politically powerful, and the US uses trade deals to pressure other countries to follow its approach to regulation. Throughout this election the Conservative party has made repeated claims that “the NHS is off the negotiating table”, but has not followed up with any efforts to turn this promise into reality.

Related: A US trade deal could cost the NHS tens of millions. My investigation shows how | Antony Barnett

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US biotech M&A: gene genies
Published: 29 Nov 2019 | 15:00 UTC

Rewards can be dazzling when Big Pharma takes the bait

Sheaya Herbs tablets by Kulchaya
Published: 29 Nov 2019 | 5:00 UTC

Sheaya Herbs tablets by Kulchaya pose a serious risk to your health and should not be taken

Innovative finance schemes increase access to medicine
Published: 29 Nov 2019 | 4:30 UTC

Bulk purchasing guarantees help overcome manufacturers’ reluctance

FT Health: Innovation in Healthcare
Published: 29 Nov 2019 | 4:30 UTC

FT writers examine technical and policy developments that could have a real impact in the drive for universal health coverage, from drone initiatives in Malawi to new finance mechanisms that ‘de-risk’ deals for companies producing medical supplies for poorer countries

PURE BIOTHROID-B No1 Tablets
Published: 29 Nov 2019 | 3:00 UTC

PURE BIOTHROID-B No1 tablets pose a serious risk to your health and should not be taken

China pharma: the promised land
Published: 28 Nov 2019 | 14:58 UTC

Cutting drug prices to gain entry to a growing market comes at a cost

UK regulator seeks to reinstate £90m fine against Pfizer and Flynn
Published: 28 Nov 2019 | 14:26 UTC

CMA appeals against decision to overturn penalty for 2,600% price rise of epilepsy drug

Global drugmakers strike deal to slash prices in China
Published: 28 Nov 2019 | 13:07 UTC

The cuts on almost 100 drugs will see them added to a nationwide insurance scheme

Update on safety and performance concerns of suspended breast implants
Published: 28 Nov 2019 | 7:30 UTC

Further details regarding the safety and performance concerns of the breast implant devices which have been suspended has been published

A further step towards an EU-wide collective action
Published: 28 Nov 2019 | 0:00 UTC

Today representatives of EU member states agreed on a mutual position regarding the Commission's Proposal for a Directive on representative actions for the protection of the collective...

The Guardian view on Boris Johnson and the NHS: a problem of trust | Editorial
Published: 27 Nov 2019 | 18:56 UTC

The prime minister’s promise to protect the health service in trade talks is made worthless by his record of lies and broken pledges

Whether Conservatives can be trusted with the NHS is an old question at election time. Whether Boris Johnson can be trusted on anything is an issue for the current campaign. The two questions make a dangerous combination for the Tory leader, who is expecting the country to believe that he would protect the health service in a post-Brexit trade deal with Donald Trump.

There is not much reason to believe that he would. On Wednesday Labour sought to probe that concern, revealing documents containing a full account of preliminary discussions between US and UK officials.

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ASX/NASDAQ ANNOUNCEMENT: Re-domiciliation to the United States
Published: 27 Nov 2019 | 0:00 UTC

The Schemes are subject to court approval, as well as approval by Benitec Shareholders (in respect of the Share Scheme) and by Benitec Warrant Holders

US FDA 510(k) Clearance for Protein Calorie Malnutrition Assessment
Published: 27 Nov 2019 | 0:00 UTC

The claims around PCM are to aid clinicians who are using Subjective Global Assessment (SGA) tools to assess patients at risk of PCM.

How to Write the Best Cover Letter for a Research Scientist Job
Published: 26 Nov 2019 | 0:00 UTC

This article offers a basic roadmap for getting started writing your cover letter for a research scientist job.

Promise Proteomics positions itself on the diagnostics and personalised medicines market with its “mAb-X-mise” range of products
Published: 26 Nov 2019 | 0:00 UTC

Promise Proteomics, the Grenoble-based experts in protein quantification in biological samples, announce that they are launching their first product on the diagnostics and personalised medicines market with their mAb-X-mise range of diagnostic kits for the therapeutic follow-up of biologics.

FDA delays draft rule for QSR/ISO 13485 harmonization
Published: 25 Nov 2019 | 0:00 UTC

The U.S. Food and Drug Administration (FDA) indicated that the long-anticipated proposed rule modernizing the Quality System Regulation (QSR) is now targeted for release in April 2020.

Data class actions guide
Published: 21 Nov 2019 | 0:00 UTC

Does your processing of personal data fall within the scope of the GDPR? Are you ready to defend potential data-related litigation – in particular, data class actions?

It took the cystic fibrosis community years to win this lifesaving drug. It can’t be taken away | Isabelle Jani-Friend
Published: 20 Nov 2019 | 15:09 UTC

Orkambi, once too expensive for the NHS, has brought hope to thousands. A new UK-US trade deal could see its price rise again

For the first time in my life I now feel able to consider a more fulfilled and “normal” life. Picking up a cold and ending up in hospital may no longer be my reality and the thought of reaching middle-age seems more realistic. This follows the huge victory of cystic fibrosis patients and the parents of children with the condition to get access to life-changing drugs on the NHS across the UK.

I was diagnosed with cystic fibrosis when I was six. I’m now 21, and since then have been under a strict medical regime which sees me spend three hours a day undergoing treatment; a combination of 30 tablets a day, inhaled medications and constant physiotherapy. Despite my daily routine, I also get admitted into hospital when I pick up a lung infection, leaving me in a hospital isolation room for two weeks at a time. This takes me away from my family and friends, and has had a huge impact on my education and work opportunities.

The years of struggle by people with CF to gain access to these drugs has taken its toll

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Hogan Lovells represents LabCorp in an offering of over US$1billion in senior notes and a concurrent US$300 million cash tender offer
Published: 20 Nov 2019 | 0:00 UTC

New York, 20 November 2019 – Global law firm Hogan Lovells is representing LabCorp, a leading global life sciences company, in an offering of over US$1 billion principal amount of senior...

Ying Da Wang tablets
Published: 19 Nov 2019 | 7:30 UTC

Ying Da Wang tablets pose a serious risk to your health and should not be taken

Appealing a denial of a drug/medical device export certificate: FDA final guidance
Published: 19 Nov 2019 | 0:00 UTC

Drug and medical device manufacturers seeking to export a product from the United States may need to obtain from the U.S. Food and Drug Administration (FDA) a Certificate to Foreign...

AI and Drug Development: IP and data protection challenges
Published: 19 Nov 2019 | 0:00 UTC

Artificial intelligence (AI) is not new to the life sciences industry but its use in drug development is rapidly growing, as life sciences companies increasingly recognize the benefits of...

Heather Ashton obituary
Published: 18 Nov 2019 | 17:28 UTC

Psychopharmacologist who started a clinic for people addicted to tranquillisers and wrote a manual on how to quit them safely

One day in the early 1980s a distressed patient went to see the doctor Heather Ashton at her pharmacology clinic in the Royal Victoria hospital, Newcastle upon Tyne.

The patient had been given the tranquilliser Ativan (lorazepam) to relax her muscles before an operation and now feared she was addicted to the drug. Ashton listened to her patient and many others like her, studied their problems scientifically, and concluded that addiction to benzodiazepine tranquillisers was a serious problem, associated with severe withdrawal symptoms. The manual she went on to write on how to quit benzodiazepines safely now provides the basis for practice all over the world.

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Revealed: NHS running short of dozens of lifesaving medicines
Published: 18 Nov 2019 | 6:00 UTC

Internal document seen by the Guardian shows low supplies for heart, cancer and anti-epilepsy drugs

The NHS is running short of dozens of lifesaving medicines including treatments for cancer, heart conditions and epilepsy, the Guardian has learned.

An internal 24-page document circulated to some doctors last Friday from the medicine supply team at the Department of Health and Social Care (DHSC), headed “commercial-sensitive”, listed many drugs currently hit by shortages at the NHS.

Related: Brexit ‘already causing medicine shortages’ at pharmacies in England

Cyanide poisoning drug: the sole supplier is experiencing long term out of stock issues.

Diamorphine: “insufficient stock to cover full forecasted demand in both primary and secondary care”.

Anti-epilepsy drug: “Patients should normally be maintained on the same brand. However … will be out of stock … until March 2020”.

Tuberculosis medication: two suppliers are out of stock, a third has some stock “but is unable to support any uplift in demand”.

Dementia drug: need to change type and frequency of dose, which could be confusing for dementia patients.

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Current status of breast implant products in Australia
Published: 18 Nov 2019 | 4:45 UTC

The list of current ARTG entries for breast implants has been updated

Artist Nan Goldin leads die-in at V&A over use of Sackler name
Published: 16 Nov 2019 | 22:01 UTC

Campaigners target £2m museum coutyard over family fortune linked to painkiller Oxycontin

“We all choose our fight and this is mine,” said the art photographer Nan Goldin on Saturday as she led a protest in the Sackler courtyard entrance of the Victoria and Albert Museum.

The action was part of her campaign to stop British and American cultural organisations accepting donations and sponsorship from the family behind the pharmaceutical company that made the addictive opioid painkiller OxyContin.

Related: Nan Goldin review – Gut-wrenching, brilliant and beautiful. I cannot turn away

The V&A supports the public's right to peaceful protest. We are grateful for the generosity of our donors

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Corbyn vows to protect NHS from US drugs firms
Published: 16 Nov 2019 | 21:21 UTC

Labour leader accuses Johnson of cover-up about trade talks between UK and US on widening access for US firms

A Labour government will pass an emergency “NHS protection” law if it wins the general election, to ensure that powerful US pharmaceutical companies cannot infiltrate the health service and dramatically force up the price of drugs, Jeremy Corbyn announces on Sunday.

Writing in the Observer, Corbyn accuses Boris Johnson’s government of a covering up the details of secret talks that British and US officials have held to discuss greater access for American companies to the UK drugs market under a post-Brexit trade deal.

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Labour will exclude the NHS and medicines from trade deals with the US | Jeremy Corbyn
Published: 16 Nov 2019 | 19:29 UTC

Donald Trump wants the big US pharmaceutical companies to get its hands on our public services – and the Conservatives are conniving to help the sell-off

There is a plot against our NHS. Boris Johnson is engaged in a cover-up of secret talks for a sell-out American trade deal that would drive up the cost of medicines and lead to runaway privatisation of our health service.

Related: Corbyn vows to protect NHS from US drugs firms

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Hogan Lovells advises Celgene in its latest strategic collaboration with Skyhawk Therapeutics
Published: 15 Nov 2019 | 0:00 UTC

New York, 15 November 2019 – Global law firm Hogan Lovells advised Celgene Corporation in its second global strategic collaboration with Skyhawk Therapeautics. The deal closed on 12...

De2Xy capsules
Published: 13 Nov 2019 | 23:00 UTC

De2Xy capsules pose a serious risk to your health and should not be taken

Me2Shape capsules
Published: 13 Nov 2019 | 5:30 UTC

Me2Shape capsules pose a serious risk to your health and should not be taken.



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