AbbVie has announced that the National Institute for Health and Care Excellence (NICE) has issued a final appraisal document recommending the dexamethasone intravitreal implant – also known as Ozurdex…
Last year, Amgen paid taxes equivalent to just over 12% of its nearly $7 billion in pre-tax profits, well below the U.S. corporate rate of 21%. The year before, the California-based biotechnology comp…
Novartis has recorded two deaths after treatment with its spinal muscular atrophy gene therapy Zolgensma, once again bringing gene therapy’s safety into attention.
A new targeted treatment for breast cancer could reshape how doctors classify and treat the disease, offering another option for people whose tumors have spread or are unable to be removed through sur…
While the FDA's inspection activities suffered amid the COVID-19 pandemic, several notable citations surfaced over the past year and a half. Those rebukes run the gamut from warning letters and Forms …
Gilead Sciences will acquire U.K.-based startup MiroBio, which is developing antibody drugs for autoimmune disorders, in a $405 million deal announced Thursday.
Pfizer once harbored blockbuster hopes for Eucrisa to be the next big topical treatment for inflammatory skin diseases. But the ointment never gained traction thanks to side effects and reimbursement …
Tallac Therapeutics has announced that the first patient has been treated with TAC-001 in a phase 1/2 clinical trial for patients with advanced or metastatic solid tumours.
The U.S. government has reached a deal with Moderna to buy 66 million doses of the biotechnology company’s updated COVID-19 booster shot this year, promising up to $1.74 billion in exchange.
We are delighted to announce that we will be running our Autumn Ethics & GCP Forum online via Zoom on the 11th October 2022. If you are unavailable to attend the webinar we will be providing a ful…
The FDA’s oncology department has lately been tightening its act around accelerated approvals and stressing the importance of patient survival data. Several companies immediately fell in line, withdra…
The NHS App enabled 1.8 million repeat prescriptions to be ordered in June 2022 alone
Biogen is trying to escape the dark Aduhelm cloud hanging over its Alzheimer's disease drug launch. So far, the launch has triggered layoffs, a CEO switch and much more.
Roche, the Breast International Group, Institut Jules Bordet Clinical Trials Support Unit and Frontier Science Foundation have announced updated data from the phase 3 APHINITY study into HER2-positive…
AstraZeneca is going all out for its new Farxiga kidney disease label: This year, it’s already started a new DTC campaign for the drug, and it more recently highlighted the “silent” nature of the dise…
People living with diabetes could be set to benefit from a major research initiative aimed at establishing a link between diabetes and heart disease – two of the most pressing global health crises.
Highly anticipated study readouts in cancer, Alzheimer’s disease and schizophrenia could determine whether the biotech industry’s slump continues.
Bristol Myers Squibb has announced that the National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination recommending Opdivo (nivolumab) for the adjuvant treatme…
For months, the industry has waited patiently as Novartis mulls the fate of its $25 billion generics arm. Now, it appears a spinoff could be in the cards.
The first ever treatment for broken heart syndrome – also known as Takotsubo cardiomyopathy – is to be trialled by researchers at the University of Aberdeen.
So far in 2022, the Food and Drug Administration’s main review office has approved 16 new medicines. The agency has recently cleared between 45 to 50 treatments each year, so the second half of the ye…
Novartis has announced that the European Commission (EC) has approved Tabrecta – also known as capmatinib – as a monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC…
Generic competition, a complete response letter, a new acquisition and external pressures have created a perfect storm for UCB, leading the company to reduce its profit forecast for 2022.
Sanofi and GSK have announced positive data from their vaccine trial which evaluated an adjuvanted Beta vaccine candidate. This included 75.1% efficacy in previously infected participants.
Verzenios in combination with endocrine treats people with early breast cancer who are at high-risk of recurrence
An experimental and closely followed drug for Alzheimer’s disease has failed a key clinical study, dealing yet another blow to the prevailing theory on how to treat a neurodegenerative illness that af…
A death risk signal has taken a toll on Clovis Oncology’s already lagging ovarian cancer drug, Rubraca. The company has taken FDA's hint, withdrawing the med in a late-line setting, but it remains und…
For the second time in two days, advisers to the Food and Drug Administration gave their unanimous support to an experimental gene therapy for a rare inherited disease, agreeing its benefits outweigh …
AstraZeneca and Daiichi Sankyo's Enhertu looked on track to open a new breast cancer category: HER2-low. Singapore's Tessa Therapeutics grabbed $126 million in a series A to advance its CAR-T programs…
Since their PCSK9 drugs to lower bad cholesterol won FDA approvals a month apart in the summer of 2015, Amgen and Regeneron have waged a war for supremacy in the market—with the California-based drugm…
Pfizer has become the most reputable pharma company for cancer patient groups, knocking Roche out of the top spot.
The National Institute for Health and Care Excellence (NICE) has recommended Roche’s faricimab (Vabysmo) as a treatment option for two leading forms of sight loss. Faricimab, an eye injection, is reco…
Count Broadway star Taye Diggs as the latest addition to sleep drug maker Idorsia’s celebrity arsenal. Just a few weeks after its insomnia drug Quviviq hit the market, the company said it has signed t…
For years, Merck & Co. has had an upper hand over its chief cancer drug competitor Bristol Myers Squibb. In March, however, Bristol Myers beat Merck to a notable milestone by winning U.S. approval…
We are pleased to announce our annual Project Management Forum will be held on
Friday 30th September at IQVIA - Reading
Understanding Project Management can be a nightmare.
More than two decades ago, Glaxo Wellcome and SmithKline Beecham combined to become GlaxoSmithKline. But as the British Big Pharma looks to slim down its organization with its consumer demerger, its l…
Data shows that 1.2 million additional NHS patients are currently eligible for vital medicines but are missing out
This is the third week in our Most Influential People in Biopharma series, following features on CEOs and scientists earlier this month. The last section profiled influential regulators and advocates.…
The Food and Drug Administration has refused to approve two cancer treatments developed by Chinese drugmakers, citing trial design in one rejection and manufacturing issues in the other.
Norfolk and Norwich University Hospitals Foundation Trust opens centre to increase survival rate among pregnant women managing other conditions
About 200 million doses of COVID-19 vaccine are gathering dust in warehouses of the world’s largest vaccine manufacturer as global demand ebbs.
The outcome, no longer seen as a sure bet, could influence how future drugs for a deadly heart disease are developed.
Researchers were able to detect specific combinations of genetic alterations which may hold key to the growth of cancers
All of our delegates and members who had course places postponed over the last two years due to covid restrictions/illness have now been contacted directly by the Secretariat. If you had a place booke…