News from the World of Clinical Research

NICE recommendation expands patient eligibility for AbbVie’s Ozurdex

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…

Amgen’s low tax rates draw attention of top Democratic senator

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…

2 deaths after Novartis' Zolgensma put gene therapy's liver safety in the spotlight once again

Novartis has recorded two deaths after treatment with its spinal muscular atrophy gene therapy Zolgensma, once again bringing gene therapy’s safety into attention.

FDA approves AstraZeneca, Daiichi drug in breast cancer first

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…

The most significant FDA citations of 2021-2022

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 …

How a small UK biotech ended up in Gilead’s hands

Gilead Sciences will acquire U.K.-based startup MiroBio, which is developing antibody drugs for autoimmune disorders, in a $405 million deal announced Thursday.

Aiming to avoid Pfizer's Eucrisa failure, Arcutis wins FDA nod for Zoryve cream in psoriasis

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 announces first patient treated with TAC-001

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.

US secures updated COVID boosters in $1.7B deal with Moderna

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.

ICR Autumn ONLINE Ethics & GCP Forum

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…

FDA puts the microscope on 2 more cancer approvals without voluntary withdrawals

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…

NHS app reaches new milestone

The NHS App enabled 1.8 million repeat prescriptions to be ordered in June 2022 alone

After failed Alzheimer's launch, Biogen writes off the remaining value of its Aduhelm inventory

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.

Royalty Pharma buys rights to top-selling GSK drug in pair of deals

• Royalty Pharma, which calls itself the largest buyer of biopharmaceutical royalties, said Wednesday it’s undertaking a two-pronged transaction to acquire royalty rights to GSK’s blockbuster respirat…

Roche’s combination breast cancer treatment delivers positive results

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 continues Farxiga push, enlists Health2Sync for a digital approach to diagnosing kidney disease

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…

Diabetes patients to benefit from £10m heart disease data investment

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.

10 clinical trials to watch in the second half of 2022

Highly anticipated study readouts in cancer, Alzheimer’s disease and schizophrenia could determine whether the biotech industry’s slump continues.

NICE recommends Opdivo as post-surgery treatment

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…

Novartis, staring down tough market for M&A, leans toward $25B Sandoz spinoff: Bloomberg

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.

First treatment for ‘broken heart syndrome’ trialled

The first ever treatment for broken heart syndrome – also known as Takotsubo cardiomyopathy – is to be trialled by researchers at the University of Aberdeen.

5 FDA decisions to watch in the third quarter

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 lung cancer drug Tabrecta gets approval

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…

UCB lowers 2022 profit expectations amid Ukraine war, rising costs

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 report successful efficacy results against Omicron

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.

NICE recommends Eli Lilly’s breast cancer therapy

Verzenios in combination with endocrine treats people with early breast cancer who are at high-risk of recurrence

Roche Alzheimer's study fails in another setback to a long-tested hypothesis

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…

Amid death risk fears, Clovis pulls Rubraca in 3rd-line ovarian cancer as PARP player plugs away at earlier setting

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…

FDA advisers offer unanimous support to second Bluebird gene therapy

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 …

Fierce Pharma Asia—Enhertu's standing ovation; Tessa's $126M CAR-T financing; Samsung's manufacturing deal

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…

GSK claims first positive Phase 3 result for an RSV vaccine

• GSK’s experimental vaccine for respiratory syncytial virus prevented disease in adults 60 and older, the company said Friday, clearing the way for the British drugmaker to ask regulators later this …

Regeneron's cholesterol drug war heats up with lawsuit over Amgen's 'illegal' bundling scheme

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…

Bristol Myers’ autoimmune drug shows potential in lupus

• Bristol Myers Squibb’s experimental autoimmune disease drug deucravacitinib helped treat moderate-to-severe lupus in a Phase 2 trial, the company reported Wednesday. Results, which were presented at…

Pfizer topples oncology giant Roche in cancer patient groups' reputation list

Pfizer has become the most reputable pharma company for cancer patient groups, knocking Roche out of the top spot.

Thousands to potentially benefit from Roche treatment for sight loss

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…

Idorsia taps more star power, enlisting actor Taye Diggs to pitch newly launched insomnia drug Quviviq

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…

Merck study results signal blood cancer potential for new type of immunotherapy

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…

ICR Project Management Forum - Friday 30th September at IQVIA - Reading

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.

• Exactly what is the ro…

GlaxoSmithKline is no more: Meet the scaled down 'GSK'

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…

NHS patients missing out on new medicines that could extend lives

Data shows that 1.2 million additional NHS patients are currently eligible for vital medicines but are missing out

Most influential people in biopharma—the entrepreneurs

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.…

FDA rejects two China-developed cancer drugs

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.

University launches hub for pregnant women with pre-existing medical conditions

Norfolk and Norwich University Hospitals Foundation Trust opens centre to increase survival rate among pregnant women managing other conditions

Roche cancer immunotherapy fails another trial, casting doubt on emerging drug class

• A drug combination including Roche’s experimental immunotherapy tiragolumab failed one of two main goals in a Phase 3 trial in a common form of lung cancer, a setback that casts doubt on the potenti…

With 200M unused doses, AstraZeneca's COVID vaccine partner Serum Institute halts production

About 200 million doses of COVID-19 vaccine are gathering dust in warehouses of the world’s largest vaccine manufacturer as global demand ebbs.

How a surprise finding made an Alnylam study one of biotech’s most ‘polarizing’ trials

The outcome, no longer seen as a sure bet, could influence how future drugs for a deadly heart disease are developed.

DNA analysis uncovers new cancer treatment clues

Researchers were able to detect specific combinations of genetic alterations which may hold key to the growth of cancers

Troubling data leads a biotech to pull its prized drug from market and FDA review

• The New York-based biotechnology company TG Therapeutics has decided to pull its only approved medicine from the market, after recent clinical trial data showed a potentially increased risk of death…

Course Postponements Due to Covid

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…