Bristol-Myers Squibb

Abecma hits the mark in earlier-stage multiple myeloma

Bristol-Myers Squibb is on course to move its BCMA-targeting CAR-T therapy further up the treatment pathway in multiple myeloma, after reporting that it met its objectives in a phase 3 trial. 2seventy bio-partnered Abecma (idecabtagene vicleucel) is already approved as a fourth-line or later therapy for the blood cancer, and the KarMMa-3 study is designed …

Abecma hits the mark in earlier-stage multiple myeloma Read More »

BMS reports data that could give its cell therapy an edge over rival J&J product

Bristol Myers Squibb has data showing that its multiple myeloma treatment Abecma beat the standard of care, preliminary Phase 3 results that could support moving the FDA-approved CAR T-cell therapy into an earlier line of treatment—ahead of a rival cell therapy. In other BMS cell therapy news, the pharma giant started an R&D alliance focused …

BMS reports data that could give its cell therapy an edge over rival J&J product Read More »

BMS adds to IBD pipeline with $1.9bn GentiBio deal

Bristol-Myers Squibb has formed an R&D partnership with GentiBio, aimed at developing regulatory T cel (Treg) therapies for inflammatory bowel disease (IBD). The deal includes an undisclosed upfront payment from BMS, with GentiBio also in line to receive milestone payments of up to $1.9 billion, as well as royalties on any future sales. The partners …

BMS adds to IBD pipeline with $1.9bn GentiBio deal Read More »

AI tissue analysis enables rapid discovery of drug candidates

AI could address the most significant issue in drug discovery, finds Ben Hargreaves, and also offers the potential to use tissue samples to create precision medicine for specific patient groups. The scale of the challenge Cancer is the second leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, according to the …

AI tissue analysis enables rapid discovery of drug candidates Read More »

BMS’ plan to move Opdivo into adjuvant RCC gets knocked back

Bristol-Myers Squibb has revealed that its checkpoint inhibitor combination of Opdivo and Yervoy failed a phase 3 trial as adjuvant (post-surgery) therapy for renal cell carcinoma (RCC), the most common form of kidney cancer. The disappointing outcome from the CheckMate -914 trial undermines BMS’ hopes of moving PD-1 inhibitor Opdivo (nivolumab) and CTLA4 inhibitor Yervoy …

BMS’ plan to move Opdivo into adjuvant RCC gets knocked back Read More »

Opdualag off to a flying start, says BMS CEO

Bristol-Myers Squibb’s new immune checkpoint inhibitor combination Opdualag has only been on the US market for a few weeks, but is already off to a “great start”, according to chief executive  Giovanni Caforio. Opdualag – a fixed-dose combination of LAG-3 inhibitor relatlimab and BMS’ PD-1 inhibitor Opdivo (nivolumab) – was approved as a first-line therapy …

Opdualag off to a flying start, says BMS CEO Read More »

Roche’s fast-growing eye drug Vabysmo set for EU approval

Roche has been trumpeting the rapid uptake of its new eye disease drug Vabysmo as it takes on Regeneron and Bayer’s mighty Eylea in the US – and could soon start making inroads against its rival in Europe. Vabysmo (faricimab) has been recommended by the EMA’s human medicines committee as a treatment for neovascular or …

Roche’s fast-growing eye drug Vabysmo set for EU approval Read More »

BMS’ Opdivo gets NHS use as adjuvant bladder cancer therapy

NICE has recommended routine use of Bristol-Myers Squibb’s Opdivo for the adjuvant treatment of some patients with urothelial carcinoma (UC), the most common form of bladder cancer. The guidance allows Opdivo (nivolumab) to be used after surgery in patients with muscle-invasive UC who are at high risk of the cancer coming back, and whose tumours …

BMS’ Opdivo gets NHS use as adjuvant bladder cancer therapy Read More »

Novartis eyes earlier use of PD-1 drug in oesophageal cancer

Novartis is still waiting for FDA approval of its  PD-1/PD-L1 inhibitor latecomer tislelizumab in relapsed oesophageal cancer, but is already planning a move the drug into the first-line setting. New phase 3 data from the RATIONALE 306 study have shown that previously-untreated patients with advanced oesophageal squamous cell carcinoma (ESCC) treated with tislelizumab plus chemotherapy …

Novartis eyes earlier use of PD-1 drug in oesophageal cancer Read More »

AZ takes aim at BMS’ lead in neoadjuvant NSCLC

Just weeks after Bristol-Myers Squibb claimed an FDA green light for Opdivo as a neoadjuvant therapy for non-small cell lung cancer, AstraZeneca is looking to encroach on its territory. Top-line results from the AEGEAN trial of AZ’s PD-L1 inhibitor Imfinzi (durvalumab) plus chemotherapy given pre-surgery for resectable NSCLC tumours have revealed a significant improvement in …

AZ takes aim at BMS’ lead in neoadjuvant NSCLC Read More »

BMS cancer drug’s expanded approval gives it an edge over a Gilead cell therapy

The new FDA approval for Breyanzi moves the Bristol Myers Squibb cancer cell therapy into an earlier line of treatment for an aggressive type of blood cancer. The decision also gives the pharmaceutical giant access to an additional pool of patients untapped by a rival cell therapy from Gilead Sciences.

Owkin bags $180m BMS alliance for cardiovascular clinical trials

Owkin has enticed another big pharma partner with its artificial intelligence-powered clinical development platform, Bristol-Myers Squibb, which is paying $80 million upfront to tap into its expertise. The deal is split between a Series B financing led by BMS and upfront fees, taking the total raised by the Paris, France-based start-up to $300 million, and …

Owkin bags $180m BMS alliance for cardiovascular clinical trials Read More »

ASCO22: New data backs BMS’ investment in Eisai’s first cancer ADC

Eisai’s first-ever attempt at developing an antibody-drug conjugate for cancer was rewarded with a $3.1 billion licensing deal from Bristol-Myers Squibb, and new data reported at ASCO has given a glimpse into its potential. Farletuzumab ecteribulin – also known as MORAb-202 – is being developed to treat tumours that overexpress folate receptor alpha (FRα), and …

ASCO22: New data backs BMS’ investment in Eisai’s first cancer ADC Read More »

BMS sets up Roche, Pfizer rivalry with Turning Point takeover

Bristol-Myers Squibb’s all-cash offer for Turning Point Therapeutics – which values the biotech at $4.1 billion – bolsters its position in precision oncology and gives it a lead asset that could challenge cancer medicines from Roche and Pfizer. The $76-per-share offer revolves around repotrectinib (TPX-0005), a tyrosine kinase inhibitor (TKI) targeting ROS1 and NTRK in …

BMS sets up Roche, Pfizer rivalry with Turning Point takeover Read More »

BMS bets $4.1B on lung cancer drug that could best products from Pfizer, Roche

Bristol Myers Squibb is splashing out $4.1 billion to acquire Turning Point Therapeutics, a clinical-stage biotech whose lead drug is currently in pivotal testing as a treatment for certain lung cancers. Recently reported preliminary data suggest the small molecule could have advantages over currently available drugs in the same class from rivals Pfizer and Roche.

BMS’ Opdivo gets late-stage oesophageal cancer nod from FDA

The FDA has cleared two combination drug regimens based on Bristol-Myers Squibb’s PD-1 inhibitor Opdivo for previously-untreated advanced oesophageal cancer, encroaching on territory held by Merck & Co’s rival Keytruda. The pair of new approvals are based on the results of the CheckMate-648 trial, and are for Opdivo (nivolumab) paired with chemotherapy or BMS’ CTLA4 …

BMS’ Opdivo gets late-stage oesophageal cancer nod from FDA Read More »

Pfizer’s Arena buyout looks canny, as etrasimod aces phase 3 trials

Pfizer placed a $6.7 billion bet on the outcome of two phase 3 trials of Arena Pharmaceuticals’ etrasimod in ulcerative colitis (UC) when it acquired the company earlier this year, and the gamble seems to have paid off. Yesterday, the company reported the results of the two trials of the S1P receptor modulator in patients …

Pfizer’s Arena buyout looks canny, as etrasimod aces phase 3 trials Read More »

What has Covid-19 taught us about virtual clinical trials?

At the upcoming INVEST PharmaTech virtual conference scheduled for July 26, the conversations will span myriad topics at the intersection of digital health and drug development. Register today.

BMS doubles down on BridgeBio alliance on SHP2 drugs

Bristol-Myers Squibb’s flurry of dealmaking has continued with en expansion of its partnership with BridgeBio on drugs targeting SHP2, in the hope of combining them with its cancer immunotherapy Opdivo. The deal – which is worth up to $905 million with an upfront fee of $90 million – gives BMS full control of BridgeBio’s experimental …

BMS doubles down on BridgeBio alliance on SHP2 drugs Read More »

BMS builds on BridgeBio alliance, inking deal for rights to KRAS cancer drug

Bristol Myer Squibb is getting rights to BBP-398, a contender in the chase for drugs that address difficult-to-target KRAS mutations. Meanwhile, BridgeBio Pharma receives some needed cash as it restructures in the wake of the Phase 3 failure of its lead program late last year.

BMS pays $200m to expand Evotec alliance on protein degraders

Bristol-Myers Squibb’s Celgene unit has clearly been impressed by progress in its four-year-old alliance with Evotec on protein degradation. It’s just paid $200 million to extend the partnership for eight more years and hiked its total value to a possible $5 billion. The two companies have been working on molecular glue degraders, small drug compounds …

BMS pays $200m to expand Evotec alliance on protein degraders Read More »

BMS shows what’s NEX-T for CAR T, plus its strategy for next-gen cancer cell therapy

As an oncologist, Kristen Hege first encountered cancer cell therapy research in the mid-1990s. Now as a Bristol Myers Squibb executive, she oversees efforts to improve the pharma giant’s first generation of cell therapies while also building a pipeline of next-generation treatments with better features and properties.

WMIF panel: How cell and gene therapy can overcome limitations of CAR T

CAR T cell therapies for cancer still pose challenges in manufacturing, safety, and the ability to address solid tumors. A panel at the World Medical Innovation Forum discussed efforts to improve CAR T as well as new approaches for the next generation of cell therapies.

Potential blockbuster BMS cardio drug gets FDA nod, first in rare heart disease

Bristol Myers Squibb drug Camzyos has FDA approval for treating obstructive hypertrophic cardiomyopathy, a rare and potentially fatal heart disorder. The drug is projected to become a blockbuster seller and its approval marks a payoff for BMS’s 2020 acquisition of the medicine’s developer, MyoKardia.

BMS bags FDA okay for cardiomyopathy drug mavacamten

Bristol-Myers Squibb’s has become the first company to bring a cardiac myosin inhibitor through to FDA approval, claiming a green light from the US regulator for mavacamten as a therapy for obstructive hypertrophic cardiomyopathy (HCM). Orally-active mavacamten – which was acquired by BMS when it bought MyoKardia for $13 billion in 2020 – will launch …

BMS bags FDA okay for cardiomyopathy drug mavacamten Read More »

End of the line for BMS, Nektar’s bempegaldesleukin/Opdivo alliance

Four years after Bristol-Myers Squibb paid $1.85 billion upfront to make Nektar’s bempegaldesleukin a companion drug to its cancer immunotherapy Opdivo, the alliance is being discontinued. Things were already looking shaky for the programme last month when a phase 3 trial of pegylated IL-2 drug bempeg given in combination with PD-1 inhibitor Opdivo (nivolumab) as …

End of the line for BMS, Nektar’s bempegaldesleukin/Opdivo alliance Read More »

BMS and Nektar end cancer drug alliance after two more clinical trial failures

Bristol Myers Squibb and Nektar Therapeutics are ending a cancer drug research alliance after data showed the combination of their respective drugs failed clinical trials in kidney and bladder cancers. The disappointing results come one month after the drug combo failed a pivotal melanoma clinical trial.

Cytokinetics’ heart drug omecamtiv strikes out in heart failure trial

Cytokinetics’ hopes of resurrecting cardiac myosin inhibitor omecamtiv mecarbil have suffered another setback, after the drug failed to show a benefit in a phase 3 heart failure study. In the METEORIC-HF trial, omecamtiv was unable to show an improved performance in exercise capacity among patients with heart failure with reduced ejection fraction (HFrEF) compared to …

Cytokinetics’ heart drug omecamtiv strikes out in heart failure trial Read More »

Gilead beats BMS to FDA okay for early lymphoma CAR-T therapy

Gilead Sciences’ Kite Pharma has become the first drugmaker to get FDA approval to use a CAR-T therapy after just one earlier systemic therapy, moving the approach up the treatment pathway. The US regulator has cleared Kite’s CD19-targeted CAR-T Yescarta (axicabtagene ciloleucel) for people with large B-cell lymphoma (LBCL) refractory to one earlier therapy, or …

Gilead beats BMS to FDA okay for early lymphoma CAR-T therapy Read More »

CHMP backs J&J’s myeloma CAR-T therapy Carvykti

Johnson & Johnson is in course for approval of its multiple myeloma CAR-T therapy Carvykti in the EU the next few weeks, after getting a green light from the EMA’s human medicines committee. The CHMP recommended conditional approval for Carvykti (ciltacabtagene autoleucel or cilta-cel) as a treatment for adults with relapsed and refractory multiple myeloma …

CHMP backs J&J’s myeloma CAR-T therapy Carvykti Read More »

Etrasimod data suggests Pfizer’s $6.7bn gamble on Arena will pay off

It’s only been two weeks since Pfizer closed its $6.7 billion takeover of Arena Pharmaceuticals, and it already has the positive data it was hoping for with etrasimod, the main asset in the deal. In its first phase 3 readout, oral S1P receptor modulator etrasimod met its objectives in patients with moderately-to-severely active ulcerative colitis, …

Etrasimod data suggests Pfizer’s $6.7bn gamble on Arena will pay off Read More »

BMS buys into Volastra’s cancer expertise with $1.1bn alliance

Bristol-Myers Squibb is the first big pharma to strike a deal with Volastra Therapeutics, a start-up that has developed a drug discovery platform based on chromosomal instability (CIN), a common but under-investigated feature of solid tumours. BMS is paying $30 million into the collaboration upfront, with a total deal value of $1.1 billion, for programmes …

BMS buys into Volastra’s cancer expertise with $1.1bn alliance Read More »

BMS nabs FDA nod for first drug in new class of cancer immunotherapies

Bristol Myers Squibb’s Opdualag has been approved by the FDA, a first for a drug that goes after a new cancer target called LAG-3. The drug is approved for advanced melanoma as part of a combination treatment that includes the already approved BMS cancer immunotherapy Opdivo.

BMS gets FDA OK for first LAG-3 checkpoint inhibitor

Bristol-Myers Squibb has won FDA approval for the first LAG-3 inhibitor drug ahead of its rivals  in cancer immunotherapy including Merck & Co. The US regulator cleared BMS’ LAG-3 drug relatlimab as a fixed-dose combination with its PD-1 inhibitor Opdivo (nivolumab) – under the Opdualag brand name – in patients aged 12 or over with …

BMS gets FDA OK for first LAG-3 checkpoint inhibitor Read More »

Sour taste for Nektar as bempegaldesleukin flunks ph3 test

Four years ago, Bristol-Myers Squibb paid $1.85 billion upfront to claim rights to Nektar’s bempegaldesleukin, setting it up to be companion drug to its cancer immunotherapy Opdivo. Now, that hope is looking like a bust. The PIVOT IO-001 trial of Opdivo (nivolumab) plus bempeg as a first-line treatment for advanced melanoma showed no improvement over …

Sour taste for Nektar as bempegaldesleukin flunks ph3 test Read More »

Nektar drug key to muti-billion dollar BMS deal fails pivotal test in melanoma

Bristol Myers Squibb bet more than $1.8 billion that Nektar Therapeutics’ drug could be combined with the pharma giant’s Opdivo to expand the reach of that drug to more patients. The drug combination has failed its first Phase 3 in advanced melanoma; separate studies in kidney and bladder cancers are ongoing.

BMS’ cash cow Revlimid faces first generic rivals in US

Bristol-Myers Squibb’s blood cancer blockbuster Revlimid is finally facing generic competition in the US, which will eat into revenues from a drug that made a massive $12.8 billion in sales last year. Low-cost rivals to multiple myeloma therapy Revlimid (lenalidomide) started to become available in Europe earlier this year, and have now been introduced in …

BMS’ cash cow Revlimid faces first generic rivals in US Read More »

BMS carves out a neoadjuvant niche for Opdivo in NSCLC

Bristol-Myers Squibb’s Opdivo has been playing second fiddle to Merck & Co’s Keytruda in the non-small cell lung cancer (NSCLC) market for years, but now it has a chance to take the limelight on its own. Opdivo (nivolumab) has become the first and only cancer immunotherapy to be approved in the US for the neoadjuvant …

BMS carves out a neoadjuvant niche for Opdivo in NSCLC Read More »

Biohaven pays $100M for epilepsy drug prospect; strikes deal for BMS muscle med

Neuroscience drug developer Biohaven Pharmaceuticals is expanding its pipeline to include epilepsy and spinal muscular atrophy. The drug developer is acquiring Channel Bioscience and licensing global rights to a Phase 3-ready drug from Bristol Myers Squibb.

BMS builds case for mavacamten label ahead of FDA decision

Bristol-Myers Squibb has new data backing up the value of mavacamten for obstructive hypertrophic cardiomyopathy (HCM), as it waits for a delayed verdict on its marketing application for the drug, acquired as part of its $13.1 billion takeover of MyoKardia in 2020. The phase 3 VALOR-HCM trial in adults with obstructive HCM eligible for a …

BMS builds case for mavacamten label ahead of FDA decision Read More »

FDA fast tracks Bayer’s oral anticoagulant asundexian

The FDA has granted fast-track status to Bayer’s oral Factor Xia inhibitor asundexian, which is in phase 2 testing as an anticoagulant that could offer safety advantages over current drugs. Asundexian (also known as BAY2433334) will be given a speedy review by the US regulator as a secondary preventative treatment for people with ischaemic stroke, …

FDA fast tracks Bayer’s oral anticoagulant asundexian Read More »

BMS cuts $3.15bn deal with Century for cancer cell therapies

Bristol-Myers Squibb chief executive Giovanni Caforio has promised to invest in the company’s pipeline at the virtual JP Morgan Healthcare Conference, and demonstrated that commitment by licensing up to four cancer cell therapy candidates from Century Therapeutics. BMS is paying $150 million upfront in cash and equity to kick off the alliance with another $3 …

BMS cuts $3.15bn deal with Century for cancer cell therapies Read More »

BMS puts $150M on the table in off-the-shelf cell therapy alliance with Century

Bristol Myers Squibb is partnering with Century Therapeutics, placing a $150 million bet that the biotech’s technology for engineering stem cells can produce new off-the-shelf cell therapies for cancer. If the four potential programs covered under the pact reach the market, milestone payments could bring Century more than $3 billion.

Amgen builds Otezla’s psoriasis label as rival BMS looms large

Amgen has won FDA approval for a stronger label for its oral plaque psoriasis therapy Otezla, as it prepares for competition from Bristol-Myers Squibb’s much-touted rival deucravacitinib, which could make its debut next year. The agency has cleared Otezla (apremilast) for the treatment of adult patients with plaque psoriasis, regardless of the severity of their …

Amgen builds Otezla’s psoriasis label as rival BMS looms large Read More »

Humana, Centene file antitrust suit against Gilead for HIV drug agreements

The insurers referred to deals Gilead struck with Janssen, Bristol Myers Squibb to prevent the generic version of its retroviral medications from being used as part of combination treatments. They also allege the company struck a deal with Teva to delay the release of its generic drug.

BMS’ Orencia gets FDA nod for GvHD thanks to real-world data

Bristol-Myers Squibb’s rheumatoid arthritis drug Orencia has been approved by the FDA to prevent graft versus host disease (GvHD), a serious complication of haematopoietic stem cell transplant (HSCT) used to treat leukaemias and other blood cancers. Orencia (abatacept) becomes the first drug to be approved to prevent GvHD, a condition in which donor immune cells …

BMS’ Orencia gets FDA nod for GvHD thanks to real-world data Read More »

FDA decision for BMS drug Orencia marks a first for acute graft versus host disease

Bristol Myers Squibb has notched another FDA approval for its blockbuster immunology drug Orencia, this time for preventing acute graft versus host disease in bone marrow and stem cell transplant patients. The decision makes the BMS drug the first one approved for preventing this complication of transplant procedures.

BMS joins off the shelf cell therapy chase with alliance on Immatics cancer drug

Bristol Myers Squibb is paying $150 million up front for global rights to an Immatics biologic drug designed to recruit a patient’s T cells to go after cancer cells. It’s the latest deal in the field of cancer drug developers aiming for off-the-shelf treatments intended to be easier and less expensive to manufacture, distribute, and …

BMS joins off the shelf cell therapy chase with alliance on Immatics cancer drug Read More »

Flush with COVID cash, Pfizer tables $6.7bn bid for Arena

Pfizer has found another use for the windfall profits it is making from it BioNTech-partnered COVID-19 vaccine, agreeing to buy Arena Pharma and its late-stage ulcerative colitis drug etrasimod. The $100-per-share deal values Arena at around $6.7 billion, and gives Pfizer an entry into the oral S1P receptor modulator category that puts it in contention …

Flush with COVID cash, Pfizer tables $6.7bn bid for Arena Read More »

ASH: Gilead, BMS CAR-Ts square off in relapsed lymphoma

A pair of trials have suggested that CAR-T therapies could offer an improved option for patients with large B cell lymphoma (LBCL) who have relapsed after or haven’t responded to first-line treatment. The results of the ZUMA-7 and TRANSFORM trials, reported at the American Society of Haematology (ASH) congress, could see Gilead Sciences’ Yescarta (axicabtagene …

ASH: Gilead, BMS CAR-Ts square off in relapsed lymphoma Read More »

FDA sets Sept review date for BMS’ psoriasis drug deucravacitinib

The FDA has kicked off its review of Bristol-Myers Squibb’s psoriasis therapy deucravacitinib, setting an action date of 1 September next year, as the EU and Japanese regulators also start their appraisals of the drug. If approved, deucravacitinib would become the first tyrosine kinase 2 (TYK2) inhibitor approved for the treatment of any disease, said …

FDA sets Sept review date for BMS’ psoriasis drug deucravacitinib Read More »

BMS strikes back against Merck in EU oesophageal cancer market

Merck & Co’s Keytruda become the first cancer immunotherapy to be approved as a first-line oesophageal cancer treatment in the EU earlier this year, but will now face competition from Bristol-Myers Squibb’s Opdivo. The European Commission has given a green light to Opdivo (nivolumab) with chemotherapy for previously-untreated patients with HER2-negative oesophageal, gastric and gastroesophageal …

BMS strikes back against Merck in EU oesophageal cancer market Read More »

BMS’ Catherine Owen: Hybrid communication is here to stay

The company’s senior vice president for major markets (Europe, Canada and Japan) talks about the continued evolution of pharma’s approach to communications and commercialisation. The core of Bristol Myers Squibb’s commercial business outside its home base of the US covers most of the large countries in Europe, as well as Canada and Japan. These 19 …

BMS’ Catherine Owen: Hybrid communication is here to stay Read More »

PharmaShots Weekly Snapshots (October 11 – 15, 2021)

Bristol Myers Squibb’s Zeposia (ozanimod) Receives CHMP’s Positive Opinion for Adult Patients with Moderately to Severely Active Ulcerative Colitis Published: 15 Oct, 2021 | Tags: Bristol Myers Squibb, Zeposia, ozanimod, CHMP, Positive Opinion, Adult Patients with Moderately to Severely Active Ulcerative Colitis Gan & Lee Completes P-III Studies of GL-GLA for Patients with T1D & …

PharmaShots Weekly Snapshots (October 11 – 15, 2021) Read More »

Bristol Myers Squibb’s Zeposia (ozanimod) Receives CHMP’s Positive Opinion for Adult Patients with Moderately to Severely Active Ulcerative Colitis

Shots: The CHMP’s recommendation is based on P-III True North study evaluating Zeposia as an induction and maintenance therapy vs PBO in adult patients with moderately to severely active UC The study demonstrated improvements across all 1EPs and 2EPs including clinical remission, clinical response, endoscopic improvement and endoscopic histologic mucosal improvement @10 & 52wks. If …

Bristol Myers Squibb’s Zeposia (ozanimod) Receives CHMP’s Positive Opinion for Adult Patients with Moderately to Severely Active Ulcerative Colitis Read More »

Scotland backs Cabometyx combo for kidney cancer, amid stalled NICE review

Patients in Scotland with newly-diagnosed advanced kidney cancer can now access a therapy combining Bristol-Myers Squibb’s immunotherapy Opdivo with Ipsen’s targeted drug Cabometyx, ahead of the rest of the UK and most other countries in the world. The Scottish Medicines Consortium (SMC) has backed Opdivo (nivolumab) plus Cabometyx (cabozantinib) as a first-line therapy for people …

Scotland backs Cabometyx combo for kidney cancer, amid stalled NICE review Read More »

Despite drug’s Phase 2 failure in ulcerative colitis, BMS keeps blockbuster hopes

Bristol Myers Squibb drug deucravacitinib missed the main and secondary goals of a Phase 2 study in ulcerative colitis. Despite the clinical trial failure, the drug previously posted positive Phase 3 results in plaque psoriasis and BMS still projects the molecule will become a blockbuster seller in multiple autoimmune conditions.

Failed IBD trial dents confidence in BMS’ deucravacitinib

Bristol-Myers Squibb’s hopes of extending the use of its highly-anticipated psoriasis pill deucravacitinib into inflammatory bowel disease (IBD) have been hit by a mid-stage failure in ulcerative colitis. Confidence in the first-in-class tyrosine kinase 2 inhibitor has been riding high after a pair of phase 3 trials hit the mark in psoriasis, setting up regulatory …

Failed IBD trial dents confidence in BMS’ deucravacitinib Read More »

Rumour mill says Acceleron is speeding towards $11bn sale

US biopharma company Acceleron is the next company heading for a takeover by a big pharma group – according to a Bloomberg report citing people close to the matter. Rumours of a deal have been bubbling away for a few days, driving Acceleron’s stock upwards, even before Bloomberg reported that a large pharma group is …

Rumour mill says Acceleron is speeding towards $11bn sale Read More »

Real-world study suggest AI may improve atrial fibrillation screening

An artificial intelligence algorithm already shown to be able to detect atrial fibrillation (AF) in clinical testing has also shown its worth in a real-world setting, according to its developers. The AI – developed by the Bristol Myers Squibb-Pfizer Alliance on cardiovascular disease – was developed using machine learning from a UK dataset of almost …

Real-world study suggest AI may improve atrial fibrillation screening Read More »

Appeals court reverses $1.2bn judgment against Gilead in BMS CAR-T case

Gilead Sciences’ Kite Pharma has won a key victory on appeal in its long-running dispute with Bristol-Myers Squibb over patents relating to CAR-T therapies, overturning a $1.2 billion fine levied last year. In December 2019, a jury found that Kite infringed on a patent owned by Juno Therapeutics, a division of BMS acquired through its …

Appeals court reverses $1.2bn judgment against Gilead in BMS CAR-T case Read More »

BMS gets FDA nod for Opdivo as first adjuvant bladder cancer therapy

Bristol-Myers Squibb has scored a win in its drive to get Opdivo into earlier lines of cancer therapy, getting FDA approval for the drug for post-surgical treatment of invasive bladder cancer. The new adjuvant use for Opdivo (nivolumab) is for patients with urothelial carcinoma (UC) – the most common form of bladder cancer – who …

BMS gets FDA nod for Opdivo as first adjuvant bladder cancer therapy Read More »

BMS buys into AI-designed immune drug from Exscientia

Bristol Myers Squibb has exercised an option on an immune-modulating drug candidate developed by UK artificial intelligence specialist Exscientia, paying $20 million for the buy-in as part of their $1.2 billion alliance. The unnamed drug candidate acts on an immunological kinase enzyme, which has proven hard to target using conventional drug discovery techniques because challenges …

BMS buys into AI-designed immune drug from Exscientia Read More »

GSK claims broader ’tissue-agnostic’ label for PD-1 drug Jemperli

The FDA has approved GlaxoSmithKline’s latecomer PD-1 inhibitor Jemperli for a second use that will significantly extend the patient population eligible for treatment with the drug. Jemperli (dostarlimab) can now be used to treat adults with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours – regardless of where they are located in the body – …

GSK claims broader ’tissue-agnostic’ label for PD-1 drug Jemperli Read More »

Failed trial nixes another FDA approval, this time for BMS’ Istodax

Bristol-Myers Squibb’s HDAC inhibitor Istodax has been on the US market for a decade as a treatment for peripheral T-cell lymphoma (PTCL), but will now be withdrawn from sale after a failed phase 3 trial. Istodax (romidepsin) – originally developed by Celgene – is the latest in a string of cancer drugs originally given accelerated …

Failed trial nixes another FDA approval, this time for BMS’ Istodax Read More »

BMS claims first EU okay for adjuvant oesophageal cancer immunotherapy

Bristol-Myers Squibb is in a battle with Merck & Co for position in the upper gastrointestinal cancer immunotherapy market, and has just reinforced its position with an EU approval in the post-surgery (adjuvant) setting. The European Commission has approved Opdivo (nivolumab) as the first-ever adjuvant immunotherapy for patients with oesophageal or gastroesophageal junction (GEJ) cancer, …

BMS claims first EU okay for adjuvant oesophageal cancer immunotherapy Read More »

Bristol Myers pulls Opdivo for use in liver cancer amid broader FDA scrutiny of speedy approvals

Bristol Myers Squibb blockbuster drug Opdivo is being pulled from the market after failing to meet the main goal of a confirmatory study. The voluntary withdrawal comes amid broader FDA scrutiny of cancer drugs that were given accelerated approval.

BMS pulls speedy Opdivo approval for liver cancer in US

Bristol-Myers Squibb has withdrawn its US marketing approval for PD-1 inhibitor Opdivo as a second-line, single-agent treatment for hepatocellular carcinoma, a common form of liver cancer, in people previously treated with Bayer/Onyx’s Nexavar. Opdivo (nivolumab) was awarded an accelerated approval in 2017 for second-line HCC treatment on the strength of mid-stage data, but failed to …

BMS pulls speedy Opdivo approval for liver cancer in US Read More »

Look out BMS, Cytokinetics has its eye on mavacamten’s turf

Shares in Cytokinetics surged after it reported positive mid-stage results for CK-274, a drug for hypertrophic cardiomyopathy (HCM) that could tread on the toes of Bristol-Myers Squibb’s mavacamten – acquired as part of its $13.1 billion takeover of MyoKardia last October. In HCM, the heart muscle become thickened and in some patients can obstruct blood …

Look out BMS, Cytokinetics has its eye on mavacamten’s turf Read More »

The key to psoriasis innovation? Dispelling the shadow of the JAK inhibitor

During the last two decades, the landscape for psoriasis treatment has exploded. The advent of biologic therapies at the turn of the millennium and the subsequent development of T-cell targeted therapies and tumor necrosis factor (TNF) inhibitors have given patients therapeutic options beyond traditional treatments such as topical steroids, tar preparations, oral systemics, and light …

The key to psoriasis innovation? Dispelling the shadow of the JAK inhibitor Read More »

The key to psoriasis innovation? Dispelling the shadow of the JAK inhibitor

During the last two decades, the landscape for psoriasis treatment has exploded. The advent of biologic therapies at the turn of the millennium and the subsequent development of T-cell targeted therapies and tumor necrosis factor (TNF) inhibitors have given patients therapeutic options beyond traditional treatments such as topical steroids, tar preparations, oral systemics, and light …

The key to psoriasis innovation? Dispelling the shadow of the JAK inhibitor Read More »

BMS pays $650m upfront for Eisai’s first ADC candidate for cancer

Japan’s Eisai has hit the jackpot with its first ever antibody-drug conjugate (ADC) drug candidate, attracting a licensing deal from Bristol-Myers Squibb that could top out at more than $3.1 billion.  BMS is making a hefty $650 million upfront payment to Eisai for global co-development and co-commercialisation rights to MORAb-202, which couples an anti-folate receptor …

BMS pays $650m upfront for Eisai’s first ADC candidate for cancer Read More »

EHA21: Study raises BMS’ hopes for Reblozyl in less severe disease

Bristol-Myers Squibb has taken another step towards achieving its blockbuster hopes for beta thalassaemia-associated anaemia therapy Reblozyl, after hitting the target in a phase 2 trial in patients who don’t require regular blood transfusions.  Reblozyl (luspatercept) is already approved to treat thalassaemia patients who depend on transfusions, but getting approval in patients with milder disease …

EHA21: Study raises BMS’ hopes for Reblozyl in less severe disease Read More »

BMS will file for earlier-line use of Breyanzi in lymphoma after trial win

Bristol-Myer Squibb has only just won FDA approval for its CAR-T Breyanzi in large B-cell lymphoma (LBCL), but is already eyeing an expansion into earlier-line therapy that could overtake rival therapies from Novartis and Gilead Sciences. Breyanzi (lisocabtagene maraleucel or liso-cel) was approved in February for use in LBCL patients after two prior systemic therapies, …

BMS will file for earlier-line use of Breyanzi in lymphoma after trial win Read More »

FDA sets November review date for J&J’s multiple myeloma CAR-T cilta-cel

Johnson & Johnson has secured a six-month FDA review for its multiple myeloma CAR-T therapy ciltacabtagene autoleucel (cilta-cel), narrowing the lead for Bristol-Myers Squibb and bluebird bio’s rival Abecma. The US regulator is now scheduled to complete its review of cilta-cel by 29 November for adults with relapsed and/or refractory multiple myeloma who have previously …

FDA sets November review date for J&J’s multiple myeloma CAR-T cilta-cel Read More »

Bristol Myers “dual immunotherapy” beats Opdivo alone in melanoma study

Bristol Myers Squibb reported Phase 3 data that show its experimental cancer immunotherapy relatlimab, combined with the company’s blockbuster drug Opdivo, was better at stopping melanoma from progressing. BMS will present the data at the upcoming annual meeting of the American Society of Clinical Oncology.

LAG-3 drugs take centre stage at ASCO, showing potential as next-gen immunotherapies

LAG-3 drugs from arch-rivals Bristol-Myers Squibb and Merck & Co look set to become talking points at this year’s ASCO conference after trial results showed their potential as next-generation cancer immunotherapies. Bristol-Myers Squibb made a splash ahead of the virtual conference early next month, with results showing a single infusion of its LAG-3 blocker relatlimab …

LAG-3 drugs take centre stage at ASCO, showing potential as next-gen immunotherapies Read More »

BMS embraces AI drug discovery with $1.2bn Exscientia alliance

Exscientia has signed up another big pharma partner for its artificial intelligence (AI) based drug discovery platform, this time attracting a $50 million upfront buy-in from Bristol-Myers Squibb.  BMS wants to harness Exscientia’s tech to discover small-molecule drugs across a range of therapeutic categories – including immunology and oncology – and is promising another $125 …

BMS embraces AI drug discovery with $1.2bn Exscientia alliance Read More »

BMS agrees deal worth up to $1.56bn for Agenus’ TIGIT cancer drug

Bristol-Myers Squibb has paid $200 million, and promised up to $1.36 billion in “biobucks” for exclusive rights to a cancer antibody still in the labs of US biotech Agenus, which blocks the TIGIT receptor that is emerging as an immunotherapy target. Roche is one of the leaders in research in to TIGIT – short for …

BMS agrees deal worth up to $1.56bn for Agenus’ TIGIT cancer drug Read More »

Bristol Myers writes $200M check for rights to Agenus checkpoint inhibitor

Bristol Myers Squibb already has a cancer program targeting the TIGIT protein, but in acquiring rights to Agenus’s drug, the pharma giant adds a bispecific antibody that preclinical research suggests has the potential to be the best in this drug class. BMS agreed to pay $200 million up front for global rights.

Keytruda should lose stomach cancer indication, says ODAC

The FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted to strip Merck & Co’s Keytruda of its accelerated approval in gastric and gastroesophageal junction (GEJ) cancer, despite a lack of treatment options in these patients.  The panel voted 6 to 2 that Keytruda (pembrolizumab) should not stay on the market for PD-L1–positive gastric or GEJ …

Keytruda should lose stomach cancer indication, says ODAC Read More »

FDA looks at pulling speedy approvals for three cancer drugs

FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market.  The Oncologic Drugs Advisory Committee (ODAC) is scheduled to look at the data for the three drugs – Merck & Co’s Keytruda (pembrolizumab), Bristol-Myers Squibb’s Opdivo (nivolumab) and Roche’s Tecentriq …

FDA looks at pulling speedy approvals for three cancer drugs Read More »

BMS’ deucravacitinib psoriasis pill could launch next year after outperforming Amgen’s rival

Bristol-Myers Squibb has phase 3 data from its deucravacitinib psoriasis pill, showing it outperformed Amgen’s rival Otezla in patients with moderate to severe disease. The company thinks the data from the first-in-class tyrosine kinase 2 inhibitor are strong enough to file with regulators, setting up a potential launch next year. Competition regulators required Celgene to …

BMS’ deucravacitinib psoriasis pill could launch next year after outperforming Amgen’s rival Read More »

Top 20 BioPharma Companies based on 2020 Total Revenue

Despite having the global pandemic, the biopharma companies were involved in multiple M&A, licensing deals. The major focus of the year remains the production and distribution of vaccines to combat the COVID-19 globally All the companies on our list are on the front line to combat this global crisis. The top 20 companies on the …

Top 20 BioPharma Companies based on 2020 Total Revenue Read More »

FDA approves BMS’ multiple myeloma CAR-T Abecma

The FDA has approved Bristol-Myers Squibb’s Abecma (idecabtagene vicleucel) for multiple myeloma, the first cell therapy to treat the disease. Abecma’s review was delayed after the FDA rejected a first filing in May last year, but it’s hoped that the drug could be a significant step forward in the treatment of this incurable condition. It …

FDA approves BMS’ multiple myeloma CAR-T Abecma Read More »

Bristol Myers Squibb SVP Ho Sung Cho highlights legacy and ongoing research in protein degradation  [Sponsored]

Cho discusses Bristol Myers Squibb’s research efforts in the field of protein degradation to advance potential treatments for a broad range of diseases. In a recent MedCity Pivot Podcast, he also shared insights on his approach to drug discovery, perspectives on dealing with failure, and some of the work his teams are doing in the …

Bristol Myers Squibb SVP Ho Sung Cho highlights legacy and ongoing research in protein degradation  [Sponsored] Read More »

In MedCity Pivot podcast, biopharma researcher talks about protein degradation, recent success tied to Covid-19 [Sponsored]

Ho Sung Cho, senior vice president of Biodiscovery Therapeutics at Bristol Myers Squibb, talks about lessons learned from drug discovery, recent success tied to Covid-19, and how the company is leveraging its expertise in protein degradation to develop novel therapies for blood cancers, solid tumors and other important therapeutic areas.

How digital health impacts the development and adoption of cancer immunotherapies [Sponsored]

In an interview, BrightInsight Co-founder and CEO Kal Patel, MD, offered a preview of the report, The Role of Digital Health in Immuno-oncology Therapy Development and Adoption.

Merck gets a leg-up for Keytruda in first-line kidney cancer

New phase 3 data have shored up the position of Merck & Co’s cancer immunotherapy Keytruda in the increasingly competitive first-line kidney cancer market.  The data from the KEYNOTE-581/CLEAR study reveal that the combination of PD-1 inhibitor Keytruda (pembrolizumab) with Eisai’s targeted tyrosine kinase inhibitor Lenvima (lenvatinib) reduced the risk of disease progression of death …

Merck gets a leg-up for Keytruda in first-line kidney cancer Read More »

Heat Bio’s shares ignite on Opdivo combination data in NSCLC

The pairing of Heat Biologics’ lead drug HS-110 with Bristol-Myers Squibb’s blockbuster checkpoint inhibitor Opdivo has boosted survival in patients with non-small cell lung cancer (NSCLC), sending the biotech’s share price skywards.  Interim data from a phase 2 trial of Heat’s off-the-shelf cell therapy with Opdivo (nivolumab) showed that patients treated with the duo as …

Heat Bio’s shares ignite on Opdivo combination data in NSCLC Read More »

BMS finally gets FDA OK for liso-cel, sets $410k launch price

Bristol-Myers Squibb finally has FDA approval for its CAR-T therapy liso-cel, which has been cleared by the US regulator as Breyanzi for certain forms of large B-cell lymphoma. The green light comes too late for holders of the contingent value right (CVR) BMS offered as a sweetener to its takeover of Celgene, which lapsed because …

BMS finally gets FDA OK for liso-cel, sets $410k launch price Read More »

BMS eyes May FDA verdict for MS drug Zeposia in ulcerative colitis

Bristol-Myers Squibb’s commercial hopes for new multiple sclerosis drug Zeposia have yet to bear fruit thanks to the pandemic, but it’s already cued up a second indication for the would-be blockbuster. Orally-active S1P agonist Zeposia (ozanimod) has been submitted to the FDA as a treatment for adults with moderately to severely active ulcerative colitis (UC), …

BMS eyes May FDA verdict for MS drug Zeposia in ulcerative colitis Read More »

NICE rejects BMS’ Zeposia MS pill in provisional guidance

NICE has said that the NHS should not fund Bristol-Myers Squibb’s multiple sclerosis pill Zeposia (ozanimod) for relapsing multiple sclerosis in first draft guidance. The cost-effectiveness body said that trial evidence showed Zeposia cuts the number of relapses and brain lesions compared with Biogen’s Avonex (interferon beta-1a). But in its first draft guidance NICE said …

NICE rejects BMS’ Zeposia MS pill in provisional guidance Read More »

Amgen’s Enbrel heads ICER list of unjustified US price rises

US cost effectiveness watchdog ICER found 10 examples of substantial price rises for top-selling medicines in 2019, and concluded that seven of those were not backed by any clinical evidence. The cost to the American taxpayer from those increases? Around $1.2 billion for the seven drugs alone, says the organisation, which also found that for …

Amgen’s Enbrel heads ICER list of unjustified US price rises Read More »

PharmaShots Weekly Snapshot (Jan 4-8, 2020)

Almirall and Tyris Collaborate to Develop Next Generation Gene Therapies Published: Jan 7, 2020 | Tags: Almirall, Tyris, Collaborate, Develop, Next Generation, Gene Therapies Sarepta Reports Mixed Results of SRP-9001 (rAAVrh74.MHCK7.micro-dystrophin) in Part 1 of Study 102 for DMD    Published: Jan 7, 2020 | Tags: Sarepta, Reports, Mixed Results, SRP-9001, (rAAVrh74.MHCK7.micro-dystrophin), Part 1, Study 102, …

PharmaShots Weekly Snapshot (Jan 4-8, 2020) Read More »

Evotec Receives Milestones in its Neurodegeneration Collaboration with BMS

Shots: Evotec has received $6M as milestones under its iPSC-based neuroscience alliance with BMS. The milestones follow BMS’ decision to add another drug discovery project to the partnership’s portfolio In 2016, the companies collaborated to identify disease-modifying treatments for neurodegenerative diseases The partnership b/w both the companies has found several access points into neurodegenerative diseases …

Evotec Receives Milestones in its Neurodegeneration Collaboration with BMS Read More »

BMS calls time on brain cancer trial as Opdivo misses second target

Bristol Myers-Squibb has put out another downbeat “update” announcement about its immunotherapy Opdivo in an aggressive form of brain cancer, saying that it looks unlikely to produce a survival benefit in the disease. BMS said an independent committee had reviewed data from the phase 3 CheckMate-548 trial in newly diagnosed MGMT-methylated glioblastoma multiforme and concluded …

BMS calls time on brain cancer trial as Opdivo misses second target Read More »

BMS’ Opdivo (nivolumab) Receives EC’s Approval as 2L Treatment for Unresectable Advanced and Metastatic Esophageal Squamous Cell Carcinoma

Shots: The approval is based on P-lll ATTRACTION-3 study involve the assessment of Opdivo vs CT (docetaxel or paclitaxel) for patients with esophageal cancer refractory/ intolerant to 1L combination therapy with fluoropyrimidine- and Pt.-based drugs Results: reduction in risk of death (23%); m-OS (10.9 vs 8.4 mos.); @12 & 18-mos. OS rates (47% & 31% …

BMS’ Opdivo (nivolumab) Receives EC’s Approval as 2L Treatment for Unresectable Advanced and Metastatic Esophageal Squamous Cell Carcinoma Read More »

$200M investment to advance clinical programs for Ambrx

The San Diego-based biopharma firm has several oncology therapies in development and has partnered in the past with the likes of Astellas, BeiGene and Bristol-Myers Squibb.

Fresh doubts over BMS’ merger payout as FDA delays key drug review

Holders of a risky “bet” on three Bristol-Myers Squibb drugs are looking increasingly unlikely to get their pay-out after the company said COVID-19 travel restrictions are delaying a key regulatory review. Shareholders in Celgene received a contingent value right (CVR) at the time of the company’s $74 billion merger with BMS last year, which pay …

Fresh doubts over BMS’ merger payout as FDA delays key drug review Read More »

Could an FDA inspection scupper CVR deadline for BMS’ liso-cel?

Bristol-Myers Squibb posted a solid set of financial results for the third quarter, but shares slid on investor fears that a payout tied new product approvals was in jeopardy. BMS’ stock fell a little over 2%, but the big casualty was a contingent value right (CVR) due to former shareholders in Celgene, which BMS acquired …

Could an FDA inspection scupper CVR deadline for BMS’ liso-cel? Read More »

BMS’ deucravacitinib psoriasis pill outperforms Amgen’s Otezla in phase 3

Bristol-Myers Squibb could be on the verge of a major coup in psoriasis after its deucravacitinib pill outperformed Amgen’s rival Otezla. BMS had to sell off Otezla (apremilast) as a condition of its merger with Celgene and made Amgen pay $13.4 billion in cash for the popular pill treatment, which is not quite as effective …

BMS’ deucravacitinib psoriasis pill outperforms Amgen’s Otezla in phase 3 Read More »

BMS joins forces with insitro to develop neurodegenerative treatments

insitro has landed another big biopharma partnership, signing a five-year collaboration with Bristol Myers Sqibb to develop therapies for amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD).  Neurodegenerative disorders such as ALS and FTD are considered a challenging therapeutic area, with no disease modifying treatments available today. insitro uses machine-learning technology to discover novel drug …

BMS joins forces with insitro to develop neurodegenerative treatments Read More »

FDA kicks off review of second kidney cancer combo based on BMS’ Opdivo

Bristol-Myers Squibb could be mere months away from claiming a second US approval for an Opdivo-based combination immunotherapy that will help defend its first-line kidney cancer franchise. The FDA has started a priority review of PD-1 inhibitor Opdivo (nivolumab) alongside Exelixis’ tyrosine kinase inhibitor Cabometyx (cabozantinib) in previously-untreated advanced renal cell carcinoma (RCC) – the …

FDA kicks off review of second kidney cancer combo based on BMS’ Opdivo Read More »

BMS acquires MyoKardia, maker of drugs for cardiovascular disease, for $13.1B

The companies expect the deal to close in the fourth quarter. MyoKardia’s lead drug candidate is mavacamten, which it is developing for hypertrophic cardiomyopathy and plans to submit to the FDA in the first quarter of next year.

BMS bulks up in cardio with $13.1bn takeover deal for MyoKardia

Bristol-Myers Squibb has said it will buy biotech MyoKardia in a $13.1 billion takeover that marks a step up in its development of cardiovascular drugs. The all-cash deal is mainly about MyoKardia’s mavacamten drug that BMS thinks could be a first-in-class treatment for hypertrophic cardiomyopathy (HCM) – a form of heart disease – based on …

BMS bulks up in cardio with $13.1bn takeover deal for MyoKardia Read More »

FDA approves BMS’ Opdivo and Yervoy combination in first-line mesothelioma

Bristol-Myers Squibb’s immunotherapy combination of Opdivo and Yervoy has been approved in the US in a new indication for untreated mesothelioma, a rare but aggressive form of cancer that forms in the lining of the lungs. The FDA has approved Opdivo (nivolumab) and Yervoy (ipilimumab), as the first and only immunotherapy for previously untreated unresectable …

FDA approves BMS’ Opdivo and Yervoy combination in first-line mesothelioma Read More »

BMS swoops on Forbius, snaring another immuno-oncology player

With the ink barely dry on a deal to develop Dragonfly’s lead cancer immunotherapy, Bristol-Myers Squibb’s business development team has agreed to buy Canadian biotech Forbius and its pipeline of drugs for cancer and fibrotic diseases. Since its foundation in 2011, privately-held Forbius has been working on drugs that inhibit TGF beta 1 and 3, …

BMS swoops on Forbius, snaring another immuno-oncology player Read More »

BMS signs $475m cancer immunotherapy deal with Dragonfly

Bristol-Myers Squibb has signed an agreement worth $475 million to develop a new form of cancer immunotherapy drug with US biotech Dragonfly Therapeutics. BMS is best known as an early pioneer of checkpoint inhibitor therapies, which work by flipping a biochemical switch on tumour cells that suddenly makes them visible to the immune system, allowing …

BMS signs $475m cancer immunotherapy deal with Dragonfly Read More »

FDA to decide on TG Therapeutics’ lymphoma drug early next year

The FDA has accepted TG Therapeutics’ filing for its lymphoma drug umbralisib, which if approved could compete against a combination therapy from Bristol-Myers Squibb and Roche. TG’s filing covers previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL), competing against a combination of BMS’ Revlimid (lenalidomide) and Roche’s Rituxan (rituximab), known for short as …

FDA to decide on TG Therapeutics’ lymphoma drug early next year Read More »

BMS’ Opdivo aces trial in asbestos-linked lung cancer

Bristol-Myers Squibb’s Opdivo has improved survival in a trial involving patients with mesothelioma, a form of lung cancer, getting one up over rival checkpoint inhibitor Keytruda from Merck & Co. The results of the CheckMate-743 trial showed that a combination of Opdivo (nivolumab) with low-dose Yervoy (ipilimumab) reduced the risk of death by 26% compared …

BMS’ Opdivo aces trial in asbestos-linked lung cancer Read More »

Roche’s Tecentriq claims melanoma OK, but don’t expect a sales surge

Roche’s checkpoint inhibitor Tecentriq has been cleared for another new use in the US – in melanoma – but could struggle to displace rival drugs from Bristol-Myers Squibb and Merck & Co. The FDA has approved the PD-L1 inhibitor as a combination with two targeted drugs – MEK inhibitor Cotellic (cobimetinib) and BRAF inhibitor Zelboraf …

Roche’s Tecentriq claims melanoma OK, but don’t expect a sales surge Read More »

BMS, bluebird refile FDA approval application for CAR-T therapy in myeloma

The companies’ resubmission of their application Wednesday seeking approval for idecabtagene vicleucel was in line with the timeline they provided in May, when the FDA sent a refuse-to-file letter in response to their initial submission.

BMS ‘bet’ with Celgene shareholders in balance after CAR-T refile

Bristol-Myers Squibb and bluebird bio have refiled their CAR-T therapy for multiple myeloma, leaving the outcome of a three drug “bet” with former Celgene shareholders dependent on a fast review from the FDA. BMS gave Celgene’s shareholders a “Contingent Value Right” (CVR) to sweeten the $74 billion merger last November. Each shareholder got one CVR …

BMS ‘bet’ with Celgene shareholders in balance after CAR-T refile Read More »