GSK, its consumer health spin-off Haleon and Sanofi could be on the hook for billions of dollars in potential damages over Zantac, a gastrointestinal drug pulled from the market in 2020 after it was linked to cases of cancer. That’s the conclusion of analysts at Morgan Stanley, Deutsche Bank and UBS, who have all issued …
GSK, Sanofi and Haleon ‘facing billions of dollars in Zantac liability’ Read More »
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 »
The largest pharma companies have all set themselves ambitious targets in recent years to improve representation for women and minority communities in their businesses, but are they meeting those diversity objectives? On the whole, yes, says a new study by reputation intelligence and media monitoring specialist alva, which delves through millions of content items across …
Bayer tops pharma rankings for diversity, inclusivity Read More »
Sanofi is making a €300 million investment in Chinese biotech Innovent as part of a collaboration to bring two new cancer therapies as quickly as possible to patients in the world’s second-largest pharma market. The deal – which includes an option on a second €400 million investment – will see the two companies jointly develop …
Sanofi looks east with €300m Innovent cancer alliance Read More »
Beijing biotech Sironax has closed a whopping $200 million second-round financing that shows investors still have a desire to back companies working on RIPK1 inhibitors despite setbacks for GSK in the class. The five-year-old Chinese company – which is developing drugs for age-related degenerative diseases – said it will use the proceeds of the Series …
Chinese biotech Sironax raises $200m for RIPK1 pipeline Read More »
Dupixent’s march towards becoming one of the world’s top-selling medicines continued at a healthy lick in the second quarter, allowing Sanofi to raise its full-year earnings forecasts. Sales of Dupixent (dupilumab) rocketed 43% to €1.96 billion ($2 billion) – ahead of analyst expectations – driven by buoyant demand in its atopic dermatitis and severe asthma …
Dupixent drives Sanofi to hike its full-year profit forecasts Read More »
Sanofi R&D in its core haemophilia category is advancing on three fronts – engineered proteins, RNA interference drugs and gene therapies – and highlighted results in two of those at the International Society on Thrombosis and Haemostasis (ISTH) congress over the weekend. First up is Alnylam-partnered RNAi candidate fitusiran, an antithrombin-targeting agent in development as …
Sanofi trumpets data with haemophilia treatment duo at ISTH Read More »
Noel Alaka, VP of Life Sciences at COTA What You Should Know: Today, oncology real-world data analytics company COTA announced the appointment of Noel Alaka as Vice President of Life Sciences. As VP of Life Sciences, Alaka will be responsible for helping grow and build partnerships with leading life sciences companies that are looking to adopt real-world data and …
Sanofi has said it will make 30 of its most commonly prescribed medicines available at non-profit prices to 40 lower-income countries, as part of a global health initiative launched by the company last year. The medicines – which include insulin, oral diabetes agent glibenclamide and cancer chemotherapy oxaliplatin – will be sold under a new …
Sanofi makes low-cost medicines pledge for low-income countries Read More »
Rising deal premiums and shrinking profit margins are threatening the sustainability of the traditional approach to mergers and acqusitions, according to a report by Accenture. The firm expects growth-minded companies will turn to other pathways.
One of the main assets of Sanofi’s $3.7 billion buyout of Principia Biopharma has run into trouble, after the FDA placed it on partial clinical hold while a safety signal is investigated. The regulator is requiring Sanofi to stop dosing some patients in phase 3 trials of the BTK inhibitor tolebrutinib (SAR442168) in multiple sclerosis …
Liver injuries prompt clinical hold on Sanofi BTK drug Read More »
The FDA placed a partial clinical hold on late-stage tests of Sanofi multiple sclerosis drug tolebrutinib after some patients developed drug-induced liver injury. While U.S. tests are paused, Sanofi said clinical testing in other countries is continuing with additional safety monitoring.
Sanofi won European Commission approval for two therapies that treat rare enzyme deficiencies. Xenpoyzme is the first treatment for acid sphingomyelinase deficiency (ASMD) while Nexviadyme is a successor to a blockbuster Sanofi drug for Pompe disease.
Sanofi has claimed approval in the EU for Xenpozyme as a treatment for acid sphingomyelinase deficiency (ASMD) – which becomes the first and only treatment option for patients with the rare disease. The European Commission has cleared Xenpozyme (olipudase alfa) for non-central nervous system symptoms in children and adults with types A/B and B ASMD, …
Celebrations for ASMD community as EU clears Sanofi’s Xenpozyme Read More »
Digital health company Health2Sync will work with Sanofi on digitising its range of insulin products in Japan, extending an earlier alliance in other markets. Health2Sync provides patient management software for doctors and mobile app for patients that is designed to help them improve blood glucose control by encouraging adherence – for example by logging insulin …
Sanofi extends Health2Sync digital diabetes partnership to Japan Read More »
BrightInsight developed the Disease Management Solution to help biopharma and medtech companies bring their Software as a Medical Device (SaMD) to market faster, according to BrightInsight CEO and Co-founder Dr. Kal Patel.
Takeda has reported positive new, long-term results in its pivotal trial of dengue fever vaccine TAK-003 that builds the case for the shot as regulators review marketing applications. The new data – coming after four-and-a-half years of follow-up – has revealed that TAK-003 cut dengue-related hospitalisations by 84%, with 61% protective efficacy against symptomatic dengue …
Takeda bolsters data for dengue jab as regulatory reviews roll on Read More »
Sanofi has launched a new initiative in its drive to integrate digital technologies throughout its business, setting up an accelerator based in Paris that will serve as the lynchpin of the effort. The accelerator has been set up to “develop products and solutions that will support Sanofi’s mission to transform the practice of medicine with …
Sanofi furthers its digital ambitions with Paris accelerator Read More »
What You Should Know: – Sanofi launched its first Digital Accelerator to better leverage data and artificial intelligence to develop solutions that address unmet patient needs. – The Digital Accelerator team is developing an integrated platform and data solution to enhance awareness of atopic dermatitis and available treatment options amongst patients and HCPs. Digital Accelerator Focus The Digital Accelerator is the next …
Sanofi Launches Its First Digital Health Accelerator to Address Unmet Patient Needs Read More »
Combination therapies are fast becoming the cornerstone of cancer treatment: not just in the UK, but across the world. With strong evidence to support how two or more medicines can work simultaneously to target different pathways in numerous ways, it’s clear that these kinds of treatments are vital in helping to change the way people …
Combination pricing: access to the future of oncology treatment relies on collaboration Read More »
Regeneron Pharmaceuticals has big plans for cancer immunotherapy Libtayo and it believes it can better execute on them if it has full control of the drug, currently partnered with Sanofi. Regeneron struck a deal to pay Sanofi $900 million, plus another $200 million in milestones, to secure full global rights to the asset.
The US Securities and Exchange Commission has sued a former AstraZeneca executive over alleged insider trading in connection with its 2019 deal to acquire rights to Daiichi Sankyo’s breast cancer therapy Enhertu. The complaint was filed against Hugues Pierre Joublin (54) – formerly global head of corporate affairs for oncology at AZ until his role …
SEC accuses former AstraZeneca exec of insider trading Read More »
Sanofi and Regeneron should hear from the FDA in the autumn whether it will approve their blockbuster immunology drug Dupixent as a therapy for rare skin disease prurigo nodularis (PN). The US regulator has granted Dupixent (dupilumab) a six-month priority review in PN and is due to deliver a verdict by 30 September, offering patients …
FDA grants speedy review to Dupixent rare skin disease Read More »
It has been eight years since Sanofi licensed rights to an over-the-counter version of erectile dysfunction (ED) drug Cialis from Eli Lilly, and the FDA has just thrown a spanner into its plans to bring it to market in the US. Sanofi said this morning that the US regulator has imposed a clinical hold on …
Sanofi and Regeneron have added another string to the bow of their immunology blockbuster Dupixent with an FDA approval in eosinophilic oesophagitis (EoE), which could help the drug reach its €10 billion peak sales target. Dupixent (dupilumab) made more than €5 billion last year from its current uses in atopic dermatitis, eosinophilic asthma and chronic …
Dupixent claims new territory in eosinophilic oesophagitis Read More »
Sanofi’s Genzyme unit has moved a step closer to securing EU approval for Xenpozyme – its enzyme replacement therapy for rare disease acid sphingomyelinase deficiency (ASMD) – after scoring a positive opinion from the CHMP. Xenpozyme (olipudase alfa) is set to become the first and only approved therapy for ASMD type A/B or ASMD type …
CHMP backs Sanofi’s Xenpozyme as first drug for ASMD Read More »
Arkansas has become the latest US state to issue a legal challenge to the big three insulin producers – Eli Lilly, Sanofi and Novo Nordisk – accusing them of deceptively driving up the price of the medicines. It has filed a lawsuit that accuses the drugmakers and pharmacy benefit managers Express Scripts, Caremark and OptumRx …
Insulin producers face fresh lawsuit in US over pricing Read More »
A pooled analysis of data for AstraZeneca and Sanofi’s respiratory syncytial virus (RSV) antibody nirsevimab has concluded that the drug is almost 80% effective at preventing lower respiratory tract infections caused by the pathogen. The data – presented this week at the European Society for Paediatric Infectious Diseases meeting – come as nirsevimab is being …
Sanofi has completed the spin-out of its pharma ingredients business EuroAPI, with shares in the new company rising more than 3% on its starting price of €12 in early trading on the Euronext exchange this morning in a declining market. The separation makes EuroAPI the world’s single largest producer of small-molecule active pharmaceutical ingredients (APIs) …
Sanofi ingredients spin-out EuroAPI rises on market debut Read More »
OMass Therapeutics has raised an impressive $100 million in a Series B financing that is said to be the largest ever for a UK biotech focusing on small-molecule drug development. The Oxford-based company said the financing, led by venture capital arms of Google and Sanofi as well as Northpond Ventures, will be used to bring …
Google, Sanofi back UK biotech OMass’ $100m second round Read More »
French drugmaker wants the efficiency of its manufacturing operations to go up a gear, and has joined forces with Formula One racing team McLaren to make it happen. The multi-year partnership will see McLaren work with Sanofi’s industrial affairs team, using its digital and analytics expertise to look at the pharma company’s manufacturing operations and …
Sanofi revs up manufacturing with help from McLaren Read More »
Experimental Roche drug giredestrant failed to meet the main goal of a Phase 2 study in advanced breast cancer. The disappointing results allow competitors to gain ground in the field of companies developing oral selective estrogen receptor degraders (SERDs), drugs that block a receptor key to driving breast cancer growth.
Roche revealed in its first-quarter results statement that giredestrant missed the mark in the phase 2 acelERA trial in advanced breast cancer, in what appears to be another blow to the emerging oral selective oestrogen receptor degrader (SERD) class. The Swiss pharma said in its update that the acelERA trial comparing giredestrant to physician’s choice …
Roche’s oral SERD giredestrant fails breast cancer trial Read More »
Sanofi has agreed another deal to flesh out its R&D pipeline, paying IGM Biosciences $150 million upfront to gain access to its engineered IgM antibody technology across six targets in oncology and immunology/inflammation. The sizeable alliance includes up to $6 billion in back-loaded milestone payments, and Sanofi says it is also considering making a $100 …
Sanofi’s R&D platform building continues with $6bn-plus IGM deal Read More »
Israeli startup Nucleai has raised $33 million in a second-round financing that will be used to further its work on using artificial intelligence and spatial biology to find biomarkers that can predict which patients will respond to cancer treatments. The five-year-old company uses machine vision and learning technology originally developed for military applications to predict …
Sanofi backs precision oncology firm Nucleai in $33m fundraising Read More »
AstraZeneca (AZ), GlaxoSmithKline (GSK), Sanofi, Allergan and Britannia Pharma have been reprimanded for running advertisements that breached the Association of British Pharmaceutical Industry (APBI) code of practice. Complaints upheld by the Prescription Medicines Code of Practice Authority (PMCPA) include two against AZ and Allergan – now part of AbbVie – related to promotion of medicines …
Latest ABPI code breaches reveal the risk of ‘likes’ on LinkedIn Read More »
Antibody drug conjugates have made scientific and regulatory progress in recent years. Sanofi is partnering with ADC specialist Seagen in a multi-drug alliance that keeps the pharmaceutical giant in the mix of this growing field of cancer therapies.
Sanofi has agreed a deal with life sciences investor Blackstone to help fund clinical trials of a new formulation of Sarclisa for blood cancer multiple myeloma, accelerating its development. Blackstone will provide €300 million in funding for the project, which will focus on a subcutaneous formulation of Sarclisa (carfilzomib) that is due to start a …
Blackstone funds new trials of Sanofi’s Sarclisa in myeloma Read More »
Shares in Sanofi were on the slide this morning after the drugmaker revealed that one of its top pipeline prospects – selective oestrogen receptor degrader (SERD) amcenestrant – stumbled in a mid-stage breast cancer trial. The phase 2 AMEERA-3 trial was testing amcenestrant in women aged 18 and over with hormone receptor-positive, HER2-negative advanced breast …
Sanofi takes a hit as hotly tipped breast cancer drug fails trial Read More »
AstraZeneca has failed in its bid to get US approval for its IL-5 inhibitor Fasenra as a treatment for chronic rhinosinusitis in people with nasal polyps, after the FDA rejected its marketing application. The US regulator has asked for additional clinical data, according to AZ, which said it remains committed to brining the drug to …
FDA says no to AZ’s Fasenra for nasal polyp indication Read More »
An experimental hemophilia A therapy from Sanofi and partner Sobi has met the goals of a pivotal study, and the pharmaceutical giant is now planning global regulatory submissions for later this year. The drug could compete against a blockbuster hemophilia A treatment marketed by Roche.
Sanofi and Sobi’s haemophilia partnership has been under competitive pressure from new therapies like Roche’s antibody Hemlibra, so the two companies are hoping a new long-acting drug candidate can revitalise the franchise. New phase 3 data on efanesoctocog alfa (also known as BIVV001) has met its objectives in a phase 3 study, providing protection from …
Sanofi, Sobi eye filings for once-weekly haemophilia A therapy Read More »
Non-profit drugmaker Civica Rx has said it will launch biosimilars of three big-selling insulin products in the US by 2024 to help diabetic patients struggling with the cost of the drugs. First launched in 2018 to to tackle shortages in lifesaving medicines and improve the affordability of drugs, Civica has now teamed up with a …
Civica plans shake-up of insulin sector with low-cost biosimilars Read More »
Here’s the big question of the day: VIVE or HIMSS or both? Jess and I offer our thoughts on both conferences and which ones we’re going to. Some deals in the past few days: ModMed buys Klara for $200 million; Nayaa raises $55 million; Sanofi and Dario Health raises $30 million; Ro acquires Dadi, an …
DarioHealth has beefed up its sales and marketing channels as well as its range of digital health products thanks to a $30 million strategic alliance with drugmaker Sanofi. Under the terms of the five-year deal, Sanofi digital health apps will be integrated into Dario’s platform and Sanofi’s sales muscle will be deployed to market the …
Sanofi forges $30m alliance with digital health firm DarioHealth Read More »
Pfizer has been awarded breakthrough status from the FDA for its respiratory syncytial virus (RSV) vaccine in pregnant women, putting the company in pole position to bring a shot to market that will protect infants from the life-threatening infection. The news comes just days after GlaxoSmithKline called a halt to enrolment and vaccination in three …
After GSK stumble, Pfizer moves forward with RSV vaccine Read More »
Sanofi’s rash of dealmaking has continued with a $2.5 billion tie-up with Chinese cancer immunotherapy biotech Adagene, focused on developing a new generation of safer antibody-based therapies. The French drugmaker is paying $17.5 million upfront to kick off the collaboration, which will see Adagene’s SAFEbody technology applied to monoclonal and bispecific antibodies for a range …
Sanofi makes another pipeline deal, tapping Adagene for antibody tech Read More »
Sanofi and digital therapeutics company DarioHealth will work together to promote the tech firm’s offerings for the management of chronic diseases. Under the $30 million, multi-year agreement, the partners will also develop new technology tools.
Sanofi and GlaxoSmithKline weathered clinical trial delays for their Covid-19 vaccine, but the partners now have data to support filings seeking regulatory authorizations. Key features of the vaccine may be able to persuade the vaccine hesitant; it may also be well-suited for use as a booster.
Sanofi and Regeneron have reported disappointing results in a trial of Dupixent in people with chronic spontaneous urticaria (CSU) who don’t respond to the only approved biologic treatment, Novartis/Roche’s Xolair. CSU is a severe form of hives that affects around 1% of the global population, causing severe itching and swelling that can last for weeks …
Dupixent falls short in phase 3 chronic spontaneous urticaria trial Read More »
A rare disease drug that Sanofi added via its $11.6 billion Bioverativ acquisition is now approved for treating the blood disorder cold agglutinin disease. The regulatory nod makes the antibody drug the first approved treatment for this rare disease that leads to anemia.
Sanofi has won FDA approval for its sutimlimab for cold agglutinin disease (CAD) at the second time of asking, becoming the first approved therapy for the rare blood disorder in the US. The complement C1s-targeting antibody – given the brand name Enjaymo – has been cleared decrease the need for blood transfusions in patients with …
Sanofi claims FDA okay for drug to treat rare blood disorder CAD Read More »
The UK scientists that ran one of the largest trials of experimental COVID-19 drugs have formed a non-profit company that will apply the methodology to other disease areas – with $6.8 million in funding from French drugmaker Sanofi. The non-profit – called Protas – is led by Sir Martin Landray, professor of medicine and epidemiology …
Team behind RECOVERY trial of COVID drugs casts its net wider Read More »
Sanofi has joined a growing list of drugmakers going after alpha-synuclein targeting drugs for Parkinson’s disease, licensing a bispecific antibody from South Korea’s ABL Bio in a deal that could be worth more than $1 billion. The French pharma group is paying $75 million upfront for the preclinical-stage drug, codenamed ABL301, a double headed antibody …
Sanofi places $75m bet with ABL on popular Parkinson’s drug target Read More »
Sanofi is the latest company to strike a deal for a Parkinson’s disease drug candidate that targets the protein alpha synuclein. The asset from ABL Bio is a bispecific antibody designed to penetrate the blood-brain barrier.
Sanofi’s new alliance with artificial intelligence biotech Exscientia spans up to 15 small molecule drugs in cancer and immunology. If drugs from the partnership reach the market, Exscientia could earn as much as $5.2 billion in milestone payments.
If the last couple of days is an indication, 2022 is already shaping up to be the year of big-ticket alliances between big pharma companies and specialists in artificial intelligence-driven discovery. Shortly after Amgen unveiled its $1.9 billion alliance with Generate Biomedicines aimed initially at five drug molecules, Sanofi has announced a big expansion of …
Another big AI deal as Sanofi taps Exscientia for 15 new drugs Read More »
A Sanofi strategy shift is leading to the end of a gene-editing alliance with Sangamo Therapeutics. Though the partnership has produced encouraging early clinical data with a sickle cell therapy highly personalized to the patient, Sanofi now plans to focus on universal approaches to genomic medicines.
Sanofi and Regeneron have another challenger to their big-selling drug Dupixent for atopic dermatitis, now that the FDA has approved Leo Pharma’s rival antibody tralokinumab. IL-13 inhibitor tralokinumab has been cleared by the US regulator as Adbry as a treatment for moderate-to-severe atopic dermatitis in adults who can’t control symptoms using topical prescription therapies. The …
Leo puts target on Dupixent in US as FDA clears tralokinumab Read More »
At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. The FDA has approved the drug under the Leqvio trade name as an adjunct to maximum-dose statin drugs for people who need further LDL-cholesterol reduction to reach targets, a year …
Novartis bags elusive US approval for cholesterol drug inclisiran Read More »
Gyroscope Therapeutics and its gene therapy for the sight-robbing disease geographic atrophy (GA) has been acquired by a big pharma company – but likely not the one you would expect. Just a few weeks France’s Sanofi made a $40 million investment in Gyroscope for first refusal rights on the gene therapy – called GT005 – …
Novartis adds gene therapy for blindness with Gyroscope buy Read More »
In acquiring Amunix, Sanofi becomes the latest big pharmaceutical company to strike a deal to gain access to technology that improves the safety and efficacy of T cell engager cancer therapies. Sanofi agreed to pay $1 billion up front to buy preclinical Amunix.
Sanofi has bolstered its immuno-oncology pipeline with a $1 billion agreement to acquire Amunix Pharma of the US – its fourth bolt-on deal of 2021. South San Francisco-based Amunix specialises in T-cell engager and cytokine-based treatments for solid tumours, and is planning to advance its lead programme AMX-818 – a cell-based therapy which targets HER2-expressing …
Sanofi buys US immuno-oncology biotech Amunix for $1 billion Read More »
Johnson & Johnson’s also-ran COVID-19 vaccine has been cleared in the EU as a booster shot, although its role in the US could be impacted by new data on rare blood clots. A Centres for Disease and Control Prevention (CDC) advisory committee is scheduled to meet today to discuss the new results, according to a …
CDC eyes safety of J&J COVID jab as EU backs booster Read More »
Sanofi’s strategy to develop new messenger RNA vaccines is adding another piece. The pharmaceutical giant struck a deal to acquire Origimm Biotechnology, a startup developing therapeutic vaccines to treat skin diseases and infections.
Sanofi has added to its vaccine pipeline with an agreement to acquire Austria’s Origimm Biotechnology and its vaccine-based immunotherapy for people with acne. The French group said that ORI-001, a vaccine based on recombinant proteins from the Cutibacterium acnes (formerly Propionibacterium acnes) bacterium that is often found in acne lesions, could be the first ever …
Sanofi snaps up acne vaccine developer Origimm Bio Read More »
Sanofi has bolstered its push into mRNA-based therapies with a new licensing deal – but not as might be expected with some up-and-coming biotech company. The French drugmaker has been enticed by an artificial intelligence (AI) algorithm developed by Chinese tech giant Baidu, which controls most of China’s search engine traffic and is sometimes referred …
Chinese tech giant Baidu licenses mRNA algorithm to Sanofi Read More »
The sum represents Sanofi’s equity investment in Owkin, plus a payment to begin a research partnership covering four types of cancer. Meanwhile, Owkin said the Sanofi investment boosts the startup into unicorn status and marks the start of its Series B funding round.
Sanofi has made another investment in artificial intelligence, taking a $180 million equity stake in Franco-US startup Owkin with another $90 million in funding for a program to seek out new cancer therapies. The three-year project will focus on four types of cancer, and will deploy Owkin’s predictive biomedical AI models to find new biomarkers …
AI specialist Owkin snares $270m alliance with Sanofi in oncology Read More »
Injectable antibodies targeting PCSK9 have failed to take off as expected in the cholesterol-lowering market, but Merck & Co hopes to do much better with an oral alternative. MK-0616 has been shown to reduce LDL cholesterol by a similar margin to injectables sold by Amgen and Sanofi/Regeneron – as well as Novartis’ longer-lasting RNAi therapy …
Merck’s oral PCSK9 drug matches injectables in early trials Read More »
Sanofi is committing up to $60 million to Gyroscope Therapeutics, a clinical-stage biotech whose lead program could become the first gene therapy for a particular vision loss disorder. The deal also gives the pharma giant right of first refusal on that gene therapy in certain geographies.
French drugmaker Sanofi has made a $40 million investment in Gyroscope Therapeutics, with another $20 million potentially on offer as the UK biotech advances its clinical-stage gene therapies for ophthalmic diseases. The investment gives Sanofi rights of first refusal on GT005, Gyrocope’s lead gene therapy for geographic atrophy (GA) secondary to age-related macular degeneration (AMD), …
Sanofi winds $40m into UK gene therapy firm Gyroscope Read More »
Generic medicines are the backbone of the healthcare system. The expiry of patents of branded drugs is the essential tool in the development of generic medicines. Generics medicines are identical to the innovator medicine in strength, effect, dosage form, and route of administration. Generic drugs are cheap and equally safe and effective as the branded …
Top 20 Generics Pharma Companies Based On 2020 Revenue Read More »
Shots: The second P-III trial evaluates the efficacy and safety of Dupixent (300mg weekly) vs PBO in 240 patients aged ≥12yrs. with EoE for 24wks. The trial met its co-primary EPs i.e., reduction in disease symptoms from baseline (64% vs 41%); patients experienced a (23.78 vs 13.86 points) improvement on 0-84 DSQ scale & achieved …
LEO Reports 16-week Results of Tralokinumab in P-III ECZTRA 6 Trial for the Treatment of Moderate-to-Severe Atopic Dermatitis Published: 22 Oct, 2021 | Tags: LEO, Tralokinumab, P-III, ECZTRA 6 Trial, Atopic Dermatitis Marinomed Biotech Signs a License Agreement with Luoxin to Commercialize Budesolv (budesonide nasal spray) in Greater China Published: 22 Oct, 2021 | Tags: …
PharmaShots Weekly Snapshots (October 18 – 22, 2021) Read More »
Sanofi and Regeneron’s Dupixent has become the first biologic drug to show activity in prurigo nodularis (PN), raising the hope of a new treatment option for the rare and highly debilitating skin disease. The two companies are still waiting for the results of a second phase 3 trial, due in the first half of next …
Dupixent scores a first in rare skin disease prurigo nodularis Read More »
Shots: The P-III LIBERTY ASTHMA VOYAGE Trial evaluates Dupixent (100/200mg, q2w) + SoC in 408 children aged 6-11yrs. with uncontrolled mod. to sev. asthma The results showed a 65% avg. reduction in the rate of severe asthma attacks @1yrs.; improvement in lung function by 5.32% points @ 12wks. & as early as 2wks. & sustained …
Shots: The NICE has issued a final appraisal determination (FAD) which recommends Dupixent (dupilumab) as an add-on maintenance treatment for severe asthma The NICE recommendation is based on a LIBERTY ASTHMA QUEST trial evaluating Dupixent vs PBO in patients with severe asthma with high exacerbation rates and high biomarkers indicating type 2 inflammation The results …
18 months after saying “no” to regular NHS funding for Sanofi and Regeneron’s Dupixent (dupilumab) for severe asthma in initial guidance, NICE has now backed the drug. The final appraisal document for Dupixent (dupilumab) has given the green light to use of the drug as an add-on maintenance therapy for people aged over 12 with …
NICE changes stance on Sanofi’s Dupixent for severe asthma Read More »
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 »
Shots: The approval is based on P-III IKEMA study assessing Sarclisa in combination with carfilzomib and dexamethasone (Kd) in 302 patients with relapsed MM who have received 1 to 3 prior lines of therapy across 69 centers spanning 16 countries The addition of Kd in Sarclisa leads to a 47% reduction in the risk of …
Shots: The P-IIb LTS part A assesses tolebrutinib (5/15/30/60mg/day) in patients with RMS and in Part B, where all participants switched to the 60mg The study demonstrated a reduction in MS disease activity as MRI and showed a favorable 1yrs. tolerability. EDSS score (2.18 to 2.65), for 60/60mg treatment group, SD score (2.65 & 2.45); …
Roche’s Actemra has been in high demand since its value in treating severe COVID-19 was established, leading to shortages. Now, Sanofi’s rival therapy Kevzara has also been hit by supply constraints. Sanofi said in a statement that supply of all four formats of Kevzara (sarilumab) – 150 mg or 200 mg pre-filled syringes or auto-injectors …
Actemra shortage spills over to include Sanofi’s rival Kevzara Read More »
Shots: The companies collaborated to evaluate Mirati’s adagrasib (KRASG12C inhibitor) + Sanofi’s SAR442720 (SHP2 inhibitor) in P-I/II dose-escalation & expansion study in patients with previously-treated NSCLC & KRASG12C mutations Adagrasib & SAR442720 demonstrated an anti-tumor activity in pre-clinical models & both have complementary MoA Sanofi will be responsible for sponsoring & operating the P-I/II study & both …
Shots: The first co-administration descriptive study evaluates Fluzone high-dose quadrivalent vaccine + Moderna’s COVID-19 mRNA booster dose (100 mcg dose) in 300 patients aged ≥65yrs. who received two doses of a COVID-19 mRNA vaccine as primary vaccination 5mos. prior to enrolment The results showed that both vaccines had similar immunogenicity responses along with similar safety …
Shots: The P-IIa study evaluates amlitelimab (IV, low/high dose, q4w over 12wks.) vs PBO in 88 patients with mod. to sev. AD inadequately controlled with topical therapies The co-primary EPs include @16wks., improvement in avg. EASI from baseline (80%/70% vs 49%) in LD/HD, no difference in responses was observed in both doses & the overall …
Already a major player in atopic dermatitis with Dupixent, Sanofi looked to expand its position in the category earlier this year when it bought Kymab and its lead drug KY1005 for the skin disorder for $1.1 billion upfront. Now, it says the drug has delivered “exciting” results in a proof-of-concept trial. KY1005 – now renamed …
Key drug in Sanofi’s $1.45bn Kymab buyout shows promise in eczema Read More »
The third quarter of 2021 highlights the approvals, clinical data & acquisitions. The new alliance observed in third quarter includes AzurRx signed a reverse triangular merger agreement to acquired First Wave Bio for ~$229M The key highlights of the big acquisition in this quarter includes Merck acquired Acceleron for ~$11.5B, Baxter acquired Hillrom for ~$10.5B, …
PharmaShots’ Key Highlights of Third Quarter 2021 Read More »
Sanofi has said that it won’t develop its mRNA-based vaccine for COVID-19 any further, even though it seemed to work in an early-stage trial, and will focus instead on another candidate partnered with GlaxoSmithKline. The French pharma group said it took the decision because mRNA vaccines from Pfizer/BioNTech and Moderna are already widely available today …
Sanofi abandons mRNA COVID jab, despite positive trial Read More »
Everest’s SPR206 Receives the NMPA’s IND Approval for the Treatment of MDR Gram-Negative Bacterial Infections Published: Sept 24, 2021 | Tags: Everest, SPR206, NMPA, IND, Approval, MDR Gram-Negative Bacterial Infections GE Healthcare to Acquire BK Medical for ~ $1.45B Published: Sept 24, 2021 | Tags: GE Healthcare, Acquire, BK Medical, ~ $1.45B Roche Presents Results …
PharmaShots Weekly Snapshots (September 20 – 24, 2021) Read More »
There’s no shortage of cancer immunotherapies trying to knock Merck & Co’s Keytruda off the top of the tree in previously-untreated non-small cell lung cancer (NSCLC). Sanofi and Regeneron have reported new data for Libtayo that suggests the drug could be a contender. Libtayo (cemiplimab) given in combination with chemotherapy looks broadly to have matched …
ESMO21: Libtayo extends survival in first-line NSCLC, challenging Keytruda Read More »
The US FDA has approved 3 BLAs and 2 NDAs in 2021, leading to treatments for patients and advances in the health care industry The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 48 novel products in 2021 Additionally, last year in 2020, the US FDA …
Insights+: The US FDA New Drug Approvals in August 2021 Read More »
Shots: The P-III PEGASUS trial evaluates pemphigus (BTK inhibitor) vs PBO in 131 patients with newly diagnosed or relapsing mod. to sev. pemphigus in 19 countries globally The trial did not meet its 1EPs or 2EPs i.e., complete remission from 29 to 37wks. with minimal doses of CS (≤10/mg day). The safety profile remained consistent …
The cash deal brings to Sanofi the Kadmon Holdings drug Rezurock, which the FDA approved in July as a treatment for chronic graft versus host disease. The French pharmaceutical giant will add Rezurock to a lineup of older products marketed globally for transplant procedures.
Less than a month after Kadmon Pharma launched its first product – Rezurock for a complication of organ transplants – the New York company has agreed to be bought by Sanofi in a $1.9 billion deal. The merger agreement, which has been agreed by the boards of both companies, will see Sanofi pay $9.50 per …
Sanofi snaps up Kadmon and its transplant drug Rezurock Read More »
Shots: Sanofi to acquire Kadmon for $9.50/share in cash making a total equity value of ~ $1.9B with a premium of 79% to a closing price of $5.30 on Sept 07, 2021. The acquisition is expected to be completed in Q4’21 The acquisition will bolster Sanofi’s transplant business with the addition of Kadmon’s Rezurock to …
Forte’s FB-401 Fails to Meet Primary Endpoints in P-II Clinical Trial For the Treatment of Atopic Dermatitis Published: Sept 3, 2021 | Tags: Forte, FB-401, P-II, Clinical Trial, Atopic Dermatitis Novartis Cosentyx (secukinumab) Receives NICE Recommendation for Patients with Plaque Psoriasis Published: Sept 3, 2021 | Tags: Novartis, Cosentyx, secukinumab, NICE Recommendation, Plaque Psoriasis Pfizer …
PharmaShots Weekly Snapshots (August 30 – September 03, 2021) Read More »
Forte’s FB-401 Fails to Meet Primary Endpoints in P-II Clinical Trial For the Treatment of Atopic Dermatitis Published: Sept 3, 2021 | Tags: Forte, FB-401, P-II, Clinical Trial, Atopic Dermatitis Novartis Cosentyx (secukinumab) Receives NICE Recommendation for Patients with Plaque Psoriasis Published: Sept 3, 2021 | Tags: Novartis, Cosentyx, secukinumab, NICE Recommendation, Plaque Psoriasis Pfizer …
PharmaShots Weekly Snapshots (August 30 – September 03, 2021) Read More »
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of August, Samsung Bioepis’ Byooviz (biosimilar, ranibizumab) received EC’s …
Shots: The P-II/III LIBERTY AD PRESCHOOL (part B) involves assessing the efficacy & safety of Dupixent (200/300mg) + low-potency TCS vs TCS alone in 162 children aged 6mos. to 5 years with uncontrolled mod. to sev. AD Result: clear or almost-clear skin (28% vs 4%); 75% or greater overall disease improvement (53% vs 11%); improvement …
Pharmaceutical companies play a vital part in our lives and in helping us to live healthier lives. The pharmaceutical industry finds, develops, manufactures, and promotes medicines or pharmaceutical drugs for usage as medications that are administered (or self-administered) to patients in order to cure, vaccinate, or relieve symptoms. Pharmaceutical companies may deal in both generic …
Top 7 Pharma Industry Leaders in 2020 By the Numbers Read More »
The US FDA has approved 6 NDAs in 2021, leading to treatments for patients and advances in the health care industry The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 43 novel products in 2021 Additionally, last year in 2020, the US FDA has approved 121 …
Insights+: The US FDA New Drug Approvals in July 2021 Read More »
Eli Lilly had a lot riding on its two phase 3 trials of IL-13 inhibitor lebrikizumab in atopic dermatitis (AD) – and it now looks like it has backed a winner. The company has claimed across-the-board wins against primary and secondary measures of efficacy in the studies, and while the data hasn’t been revealed yet, …
Look out Dupixent, Lilly’s lebrikizumab is on the march Read More »
Junshi and Coherus’s Toripalimab Receive the US FDA’s Breakthrough Therapy Designation as 1L Treatment of Nasopharyngeal Carcinoma Published: Aug 13, 2021 | Tags: Junshi, Coherus, Toripalimab, US, FDA, Breakthrough Therapy Designation, Nasopharyngeal Carcinoma Celltrion’s Regdanvimab (CT-P59) Receives the ANVISA’s EUA for the Treatment of COVID-19 in Brazil Published: Aug 13, 2021 | Tags: Celltrion, Regdanvimab, …
PharmaShots Weekly Snapshots (Aug 09 – 13, 2021) Read More »
Immunology deals with physiological functioning of the immune system in states of both health and disease as well as malfunctions of the immune system in immunological disorders With the new advancement in immune sector, global pharmaceuticals continue to grow in the field despite the disruption during the COVID-19. As in 2019, Abbvie again secured the …
Top 20 Immunology Companies Based on 2020 Immunology Segment Revenue Read More »
Sanofi has added another string to its Pompe disease therapy bow, after getting FDA approval for Nexviazyme, its latest therapy for the rare, inherited disorder. The US regulator has approved Nexviazyme (avalglucosidase alfa) for the treatment of patients aged one year of age and older with late-onset Pompe disease, which progressively attacks the heart and …
Sanofi extends its Pompe range with first Nexviazyme OK Read More »
Medtronic to Acquire Intersect ENT for ~$1.1B Published: Aug 6, 2021 | Tags: Medtronic, Intersect ENT, ~$1.1B Kite Signs a License Agreement with Appia to Develop Allogeneic Cell Therapies for the Treatment of Cancer Published: Aug 6, 2021 | Tags: Kite, Appia, Allogeneic Cell Therapies, Cancer Polpharma & Bioeq Report BLA Submission to the US …
PharmaShots Weekly Snapshots (Aug 02 – 06, 2021) Read More »
Sanofi and Regeneron’s latecomer checkpoint inhibitor Libtayo has largely been protected from heavyweight competition in its first niche markets, but now looks set to for a toe-to-toe contest with Merck & Co’s class leader Keytruda in the big non-small cell lung cancer (NSCLC) category. Keytruda (pembrolizumab) dominates first-line NSCLC treatment, where it is approved both …
Sanofi, Regeneron eye Libtayo challenge to Keytruda in first-line lung cancer Read More »
Sanofi is acquiring Translate Bio, its messenger RNA R&D partner for the past three years, in a $3.2 billion deal. The pharmaceutical and vaccines giant said the acquisition will speed up development of partnered vaccine programs and spark work on new ones in areas such as cancer, immunology, and rare diseases.
Sanofi has been forging ever-closer ties with its mRNA partner Translate Bio since the two started working together in 2018, and has now gone all in, offering $3.2 billion to buy the company outright. The $38-per-share deal – a 56% premium to Translate’s recent share price before an after-hours surge in the stock on rumours …
Sanofi swoops on partner Translate, buying the mRNA firm for $3.2bn Read More »
Shots: Sanofi to acquire all outstanding shares of Translate Bio for $38.00/share in cash making a total equity value of ~$3.2B with a premium of 30.4% to Translate Bio’s one day prior closing price of $29.15. The acquisition is expected to complete in the Q3’21 The acquisition will utilize mRNA technology to further accelerates Sanofi’s …
Roche Publishes the Results of Evrysdi (risdiplam) in FIREFISH Study to Treat of Type 1 SMA at NEJM Published: July 30, 2021 | Tags: Roche, Evrysdi, risdiplam, FIREFISH Study, Type 1 SMA, NEJM BeiGene Reports Results of Brukinsa (zanubrutinib) in P-III SEQUOIA Trial for the Treatment of Chronic Lymphocytic Leukemia Published: July 30, 2021 | …
PharmaShots Weekly Snapshots (July 26 – 30, 2021) Read More »
Generic drugmaker Mylan has become the first company to secure FDA approval for a biosimilar product that is considered completely interchangeable with the reference product – namely Sanofi’s once-daily insulin Lantus. Mylan’s Semglee has been approved for over a year as a regular biosimilar to Lantus (insulin glargine), meaning that it could be used in …
FDA okays Mylan insulin drug as first ‘interchangeable’ biosimilar Read More »
Shots: The study A of P-III LIBERTY CUPID trial evaluates Dupixent vs SoC in 138 patients aged ≥6 yrs. with CSU who remained symptomatic despite antihistamine use and who were not previously treated with anti-IgE therapeutics The trial met its 1EPs & 2EPs @24wks. i.e. showed a reduction in itch severity (63% vs 35%), reduction …
Shots: The CHMP’s positive opinion is based on P-III COMET study assessing avalglucosidase alfa that demonstrated improvements in respiratory function & movement endurance measures in people with late-onset Pompe disease The CHMP concluded that avalglucosidase alfa does not qualify as a New Active Substance (NAS). Sanofi will be requesting a re-examination of the CHMP’s opinion …
Pfizer has pledged a whopping $11 billion upfront for rights to an Arvinas drug for breast cancer from its protein degrader platform, which harnesses cells’ natural protein-denaturing machinery to remove rogue proteins associated with disease. The deal focuses on ARV-471, currently in phase 2 testing for advanced breast cancer patients whose tumours expresses oestrogen receptors …
Pfizer puts up $1bn to buy into Arvinas breast cancer programme Read More »
The EMA has kicked off a rolling review of a COVID-19 vaccine from Sanofi and GlaxoSmithKline, which started a 35,000-patient phase 3 trial in May. The vaccine – now dubbed Vidprevtyn – is based on a recombinant protein antigen developed by Sanofi’s vaccines unit Sanofi Pasteur, and also includes an immune-boosting adjuvant developed by GSK …
EMA starts review of latecomer GSK/Sanofi COVID-19 vaccine Read More »
Lysogene Receives the US FDA’s Fast Track Designation for LYS-GM101 Gene Therapy to Treat GM1 Gangliosidosis Published: July 9, 2021 | Tags: Lysogene, US, FDA, Fast Track Designation, LYS-GM101 Gene Therapy, GM1 Gangliosidosis Jazz’s Vyxeos (daunorubicin and cytarabine liposome) for Injection Receives Health Canada Approval for the Treatment of High-risk Acute Myeloid Leukemia Published: July …
PharmaShots Weekly Snapshots (July 05 – 09, 2021) Read More »
Shots: Eureka and MSK are eligible to receive up front and ~$1B as development, regulatory and sales milestone along with royalties on net sales. Sanofi gets exclusive rights to the GPRC5D binder for non-CAR use Eureka discovered the GPRC5D binding domain using its E-ALPHA Abs discovery platform, under its collaboration with MSK Additionally, targeting GPRC5D …
Sanofi Signs ~$1B Agreement with Eureka & MSK for their Multiple Myeloma Candidate Read More »
The second quarter of 2021 witnesses major acquisitions, approvals, and clinical data. There are major alliances in this quarter which include Merck signed ~$1.2B supply agreement with US Government for Molnupiravir to treat COVID-19 The big acquisition took place during the quarter including Microsoft acquired Nuance for ~$19.7B, MorphoSys acquired Constellation for ~$1.7B Our team …
PharmaShots’ Key Highlights of Second Quarter 2021 Read More »
Sanofi, already a global leader in vaccine production, has formed a new division that will focus exclusively on developing messenger RNA vaccines. The pharmaceutical giant is committing to spend €400 million annually on this new center’s mRNA R&D.
Lineage Signs an Exclusive Option Agreement with Amasa Therapeutics to Supply and Use of Clinical-Grade Hystem Published: June 18, 2021 | Tags: Lineage, Option Agreement, Amasa Therapeutics, Clinical-Grade Hystem BioNTech Reports First Patient Dosing in P-II Clinical Trial of BNT111 to Treat Advanced Melanoma Published: June 18, 2021 | Tags: BioNTech, P-II, Clinical Trial, BNT111, …
PharmaShots Weekly Snapshots (June 14 – 18, 2021) Read More »
Shots: CytoReason reports the initiation of a project with Sanofi by utilizing its cell-centered models and deconvolution techniques to counsel mechanistic insights for each asthma endotype The focus of the project is to drive a better understanding of heterogeneity in asthma patients and identify stable and reproducible asthma endotypes alongwith associated diagnostic features by using …
Shots: Part A of the P-III CADENZA trial involves assessing the efficacy & safety of sutimlimab (6.5g/ 7.5g) vs PBO in a ratio (1:1) in 42 patients with CAD without blood transfusion. The study met its 1EPs i.e. improvement in Hgb ≥1.5 g/dL from baseline @23, 25, & 26wks., avoidance of transfusions & other CAD-related …
Sanofi’s hopes of a speedy approval of first-in-class C1s inhibitor sutimlimab in rare disorder cold agglutinin disease (CAD) were dashed by the FDA, but new phase 3 data keep the drugmaker on track for a resubmission before year-end. The results of the 42-subject CADENZA study – reported at the ongoing European Haematology Association (EHA) – …
EHA21: Sanofi builds case for rare disease drug sutimlimab after FDA rejection Read More »
The ways in which HCPs prefer to engage with pharma has been changing for quite some time, and the digital transformation brought by COVID has dramatically accelerated that. In a recent pharmaphorum webinar, in partnership with Axtria, commercialisation experts from across the industry discussed how the right field force training and execution in combination with …
Experts discuss the field force’s customer-centric future Read More »
Tonix Pharmaceuticals Presents Results of TNX-102 SL in P-III RELIEF study for the Management of Fibromyalgia at ASCP 2021 Published: June 4, 2021 | Tags: Tonix Pharmaceuticals, TNX-102 SL, P-III, RELIEF Study, Fibromyalgia, ASCP 2021 Dermavant Submits NDA to the US FDA for Tapinarof Cream to Treat Plaque Psoriasis Published: June 4, 2021 | Tags: …
PharmaShots Weekly Snapshots (May 31 – June 4, 2021) Read More »
Amgen has made a play in a hot area of immunology R&D, paying $400 million upfront to claim rights to an OX40-targeting drug from Kyowa Kirin that is ready for phase 3 testing for atopic dermatitis or eczema. The deal gives Amgen rights to the KHK4083 antibody in all countries except Kyowa’s home market of …
Amgen pays Kyowa $400m upfront for OX40 eczema drug Read More »
Shortly after failing a Parkinson’s disease study, Sanofi’s venglustat has missed the mark in another trial in autosomal dominant polycystic kidney disease (ADPKD), whittling down the list of possible uses for the drug even further. Sanofi is still running studies of the glycosphingolipid (GSL) inhibitor in rare lysosomal storage diseases like Gaucher disease type 3, …
Sanofi’s venglustat bombs again, but isn’t dead yet Read More »
Shots: The company has stopped the P-II/III STAGED-PKD study for not meeting futility criteria that assess venglustat vs PBO in patients with ADPKD, following an independent analysis of the annualized rate of change in TKV The therapy did not bring a reduction in TKV growth rate and interim analysis showed the reduction of GSLs may …
Seelos’ SLS-005 (Trehalose) Receives EC’s Orphan Drug Designation to Treat Amyotrophic Lateral Sclerosis Published: May 28, 2021 | Tags: Seelos, SLS-005, Trehalose, EC, Orphan Drug Designation, Amyotrophic Lateral Sclerosis The US FDA’s EMDAC Supports Provention Bio’s Teplizumab in Delaying Diabetes Published: May 28, 2021 | Tags: US, FDA, EMDAC, Provention Bio, Teplizumab, Delaying Diabetes uniQure …
PharmaShots Weekly Snapshots (May 24 – 28, 2021) Read More »
GlaxoSmithKline’s COVID-19 drive has advanced on two fronts, with the start of phase 3 trials of its Sanofi-partnered vaccine candidate as well as an FDA emergency approval for antibody sotrovimab, developed with Vir Biotech. GSK and Sanofi think they could be on track for approval of the recombinant protein-based vaccine – delivered with GSK’s immune-response …
GSK, Sanofi eye Q4 approval as COVID jab starts phase 3 Read More »
Shots: The companies have started enrollment of patients in a P-III clinical study to assess the safety, efficacy & immunogenicity of COVID-19 vaccine candidate vs PBO in 35,000+ volunteers aged ≥ 18yrs. from multiple countries including the US The 1EP& 2EP of the study is to prevent symptomatic & asymptomatic infection respectively. A two-stage study …
Sanofi and GSK Initiate P-III Clinical Study of their COVID-19 Vaccine Read More »
Takeda has revealed long-term clinical trial results with its dengue vaccine that reinforce its safety and efficacy – and help to differentiate it from Sanofi’s challenged Dengvaxia shot. Updated results from the large-scale TIDES trial of TAK-003 show that three years after dosing it was 62% effective at warding off dengue symptoms and prevented more …
After Sanofi’s setbacks, Takeda eyes finish line with its dengue vaccine Read More »
BeiGene Reports Results of Tislelizumab + CT in P-III RATIONALE 309 Study as 1L Treatment for Recurrent or Metastatic Nasopharyngeal Cancer Published: May 21, 2021 | Tags: BeiGene, Tislelizumab, CT, P-III, RATIONALE 309 Study, Recurrent, Metastatic Nasopharyngeal Cancer Aurinia to Present Results of Lupkynis (voclosporin) in AURORA 2 Continuation Study for Lupus Nephritis at EULAR …
PharmaShots Weekly Snapshots (May 17 – 21, 2021) Read More »
Shots: The P-III VOYAGE trial involves assessing Dupixent (100/200mg, q2w, based on weight) + SOC asthma therapy in 408 children aged 6-11yrs. with uncontrolled mod. to-sev. asthma with evidence of type 2 inflammation Results: improvement in asthma control @24wks. (1.34/ 1.33 vs 0.88/ 1.00); improvement in ACQ-7-IA; reduction in mean FeNO levels to below the …
Sanofi and GlaxoSmithKline reported positive preliminary Phase 2 data for their Covid-19 vaccine. Though several vaccines have been authorized, the companies say that their vaccine’s foundation in existing influenza vaccines offers advantages, and potentially gives their candidate a place in the market as a booster shot.
UK biotech Arecor Therapeutics has announced plans to float on the London stock market, to fund plans to develop novel formulations of insulins and other biological drugs with enhanced properties. Based in Cambridge, Arecor has proprietary formulation technology and plans to licence out drugs to big pharma companies, looking for milestone payments and royalties as …
Arecor hopes London stock market float will raise profile of insulin products Read More »
Sanofi and GlaxoSmithKline seem to be getting somewhere with their COVID-19 vaccine at last, announcing plans to move to phase 3 following supportive mid-stage trial results. In a statement the companies said that if the late-stage trial and regulatory reviews go well, the vaccine is expected to be approved in the fourth quarter of this …
Sanofi/GSK move latecomer COVID-19 shot into phase 3 Read More »
Shots: The vaccine has achieved strong rates of neutralizing antibody responses, in line with those measured in people who have recovered from COVID-19, in all adult age groups in a P-II study The results showed 95%-100% seroconversion following the second injection in all age groups (18-95yrs. old) & across all doses, with acceptable tolerability & …
AzurRx BioPharma Reports Positive Interim P-II Data of MS1819 + PERT for Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency Published: May 14, 2021 | Tags: AzurRx BioPharma, P-II, MS1819, PERT, Cystic Fibrosis, Severe, Exocrine Pancreatic Insufficiency Goldfinch Bio Initiates P-I Clinical Trial of GFB-024 for the Treatment of Severe Insulin Resistant Diabetic Nephropathy Published: …
PharmaShots Weekly Snapshots (May 10 – 14, 2021) Read More »
Shots: The P-III trial involves assessing libtayo (300mg, IV, q3w) as monothx. vs CT in patients with recurrent or metastatic cervical cancer that has progressed on platinum-based CT. The companies expect the regulatory submission in 2021 The results demonstrated a 31% reduction in the risk of death in the total population, improvement in OS, PFS, …
Shots: The companies enter into a supply agreement for Alemtuzumab to be used in Cellectis’ trials as a lymphodepleting regimen for UCART22 in the BALLI-01 clinical trial to treat r/r ALL, and for UCART123 in AMELI-01 clinical trial to treat r/r AML but not for UCARTCS1 due to self-lymphodepleting activity Sanofi will provide alemtuzumab for …
Cellectis Collaborates with Sanofi for Alemtuzumab to be Utilized in CART-Cell Trials Read More »
AstraZeneca Reports Results of Imfinzi (durvalumab) and Imfinzi + Tremelimumab in P-III POSEIDON Study as 1L Treatment for Stage IV Non-Small Cell Lung Cancer Published: May 7, 2021 | Tags: AstraZeneca, Imfinzi, durvalumab, Tremelimumab, P-III, POSEIDON Study, Stage IV Non-Small Cell Lung Cancer Merck and Fusion Pharmaceuticals Enter into a Clinical Collaboration for FPI-1434 + …
PharmaShots Weekly Snapshots (May 03 – 07, 2021) Read More »
Shots: Sanofi and Stanford Medicine collaborated to initiate three “deep-dive” research projects focusing on autoimmune diseases and inflammatory conditions The partners will organize a joint committee to fund three programs in a year with an annual research forum held by Sanofi for researchers from both organizations to further exchange ideas and discuss collaborative research projects …
Sanofi has begun a three-year research collaboration with Stanford University School of Medicine, working on better understanding of immunology and inflammation through open scientific exchange. The French pharma said it plans to provide funding and scientific inputs into projects of mutual interest in several therapeutic areas including autoimmune diseases and inflammatory conditions. Sanofi’s success in …
Sanofi begins three-year immunology R&D tie-up with Stanford Read More »
Sanofi’s much anticipated drug for both haemophilia A and B – fitusiran – could be filed in 2022 despite a problem with blood clots in some patients in late-stage testing. In its quarterly results update, Sanofi notes that a revised dosing schedule is being tested in its phase 3 programme to try to reduce the …
Sanofi eyes 2022 filing for haemophilia drug fitusiran, despite safety issue Read More »
Shots: The P-III MELODY study involves evaluating Nirsevimab (50mg/100mg, IM) vs PBO to determine the incidence of medically attended LRTI due to RSV confirmed by RT-PCR testing through 150days after dosing in healthy infants in a ratio (2:1) entering their first RSV season The study met its 1EPs i.e. reduction of LRTI due to RSV …
BMS’ Opdivo + Yervoy and Onureg Receive EC’s CHMP Positive Opinion for MPM and AML Published: Apr 23, 2021 | Tags: BMS, Opdivo, Yervoy, Onureg, Receive, EC, CHMP, Positive Opinion, MPM, AML Gilead Reports NDA Submission of Filgotinib to PMDA for Ulcerative Colitis in Japan Published: Apr 23, 2021 | Tags: Gilead, Reports, NDA, Submission, …
PharmaShots Weekly Snapshots (Apr 19 – 23, 2021) Read More »
The first quarter of 2021 highlights new approvals, M&A, and the clinical data of COVID-19 vaccines. The companies expand their working in COVID-19 by targeting South African & Brazil variants along with other emerging variants Starting with the latest acquisition, Amgen acquired Five Prime for $1.9B, Jazz acquired JW while Boston acquired Preventice. This quarter …
PharmaShots’ Key Highlights of First Quarter 2021 Read More »
Shots: The approval is based on data from the P-III IKEMA study evaluating Sarclisa + carfilzomib and dexamethasone (Kd) vs Kd alone in 302 patients with relapsed MM across 69 centers spanning 16 countries Results: mPFS (not reached vs 19.15 mos.) at the time of the pre-planned interim analysis, reduction in the risk of disease …
ThermoFisher to Acquire PPD for ~$17.4B Published: Apr 16, 2021 | Tags: ThermoFisher, Acquire, PPD, ~$17.4B Roche’s Evrysdi (risdiplam) Receives Health Canada’s Approval for Spinal Muscular Atrophy in Adults and Children Published: Apr 16, 2021 | Tags: Roche, Evrysdi (risdiplam), Receives, Health Canada, Approval, Spinal Muscular Atrophy, Adults, Children GSK Discontinues the P-II Trials of …
PharmaShots Weekly Snapshots (Apr 12 – 16, 2021) Read More »
Shots: Sanofi has signed an exclusive worldwide licensing agreement with C4XD worth up to $492.94M million, for C4XD’s oral pre-clinical IL-17A inhibitor program C4XD to receive $8.33M up front and is eligible to receive up to $484.60M as development, regulatory and commercial milestones including $13.09M as pre-clinical milestones along with royalties Sanofi will develop and …
Sanofi Collaborates with C4XD for an Oral Therapy to Treat Inflammatory Diseases Read More »
A disparity in UK access to a medicine for Duchenne muscular dystrophy (DMD) has been addressed, after Scotland gave a green light to use of PTC Therapeutics’ Translarna for the first time. The Scottish Medicines Consortium (SMC) says that Translarna (ataluren) can be provided by NHS Scotland for a period of three years, once PTC …
Scotland opens door to Translarna for Duchenne muscular dystrophy Read More »
Sanofi has licensed a potential inflammatory diseases drug from Manchester University spin-off C4X Discovery Holdings in a deal worth up to €414 million ($492 million). While the headline figure looks significant the UK biotech will receive only €7 million up front, reflecting the fact that the drug has not yet begun clinical testing. The rest …
Sanofi licences in potential oral IL-17 drug from UK’s C4X Discovery Read More »
Shots: Sanofi to acquire Tidal Therapeutics for $160M up front and ~ $310M following the achievement of certain milestones The acquisition will add Tidal’s innovative mRNA-based research platform with applications in oncology, immunology, and other disease areas With its acquisition, Sanofi will further develop the technology platform to expand its research capabilities in immuno-oncology and …
Sanofi, which already has messenger RNA R&D alliances with other companies, paid $160 million up front to acquire preclinical startup Tidal Therapeutics. The pharma giant said Tidal’s mRNA approach could lead to an off-the-shelf CAR-T therapy.
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 »
Pfizer and BioNTech Report Results of BNT162b2 to Prevent COVID-19 Published: Apr 2, 2021 | Tags: Pfizer and BioNTech, Report, Results, BNT162b2, Prevent, COVID-19 Acceleron Presents Results of Sotatercept in P-II PULSAR Trial for the Treatment of Pulmonary Arterial Hypertension, Published in NEJM Published: Apr 2, 2021 | Tags: Acceleron, Presents, Results, Sotatercept, P-II PULSAR …
PharmaShots Weekly Snapshots (Mar 29 – Apr 02, 2021) Read More »
Shots: The approval is based on P-III IKEMA study involves assessing of Sarclisa + carfilzomib and dexamethasone(kd) vs SOC in 302 patients with RRMM who had received 1 to 3 prior lines of treatment The result demonstrated a reduction in the risk of disease progression or death by 45%. At pre-planned interim analysis, median PFS …
The FDA has approved Sanofi’s Sarclisa (isatuximab) in combination with a new chemotherapy regimen for advanced multiple myeloma, building on a first approval last year. This label extension covers use of Sarclisa plus carfilzomib and dexamethasone for adults with relapsed or refractory multiple myeloma, who have received one to three previous therapy lines. This new …
Sanofi’s Sarclisa gains new US multiple myeloma indication Read More »
Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, mRNA Translation Modulators, Neurological Diseases Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis Published: Mar 19, 2021 | Tags: Kiniksa, Arcalyst (rilonacept), Receives, US, FDA, …
PharmaShots Weekly Snapshots (Mar 15 – 19, 2021) Read More »
Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, mRNA Translation Modulators, Neurological Diseases Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis Published: Mar 19, 2021 | Tags: Kiniksa, Arcalyst (rilonacept), Receives, US, FDA, …
PharmaShots Weekly Snapshots (Mar 15 – 19, 2021) Read More »
In acquiring the two early-stage Sanofi drugs for sickle cell disease, Global Blood Therapeutics aims to complement Oxbryta, its FDA-approved treatment for the rare blood disorder. Meanwhile, Sanofi can turn its full sickle cell efforts on a gene-editing therapy partnered with Sangamo Therapeutics.
Sanofi and Regeneron’s checkpoint inhibitor Libtayo has become the first immunotherapy to improve survival when used as a second-line therapy in cervical cancer, setting up regulatory filings later this year. A phase 3 trial of the PD-1 inhibitor in cervical cancer patients who had progressed after first-line chemotherapy has been stopped early after an interim …
Sanofi, Regeneron prep filings for Libtayo in cervical cancer Read More »
Shots: The P-III trial involves assessing Libtayo (300mg, IV, q3w) as monothx. vs CT in patients with recurrent or metastatic cervical cancer that has progressed on platinum-based CT. The trial enrolled patients regardless of their PD-L1 status The results demonstrated a 31% reduction in the risk of death in the total population, improvement in OS, …
PhaseBio Signs a Supply Agreement with BioVectra to Support the Development and Commercialization of Bentracimab Published: Mar 12, 2021 | Tags: PhaseBio, Signs, Supply, Agreement, BioVectra, Support, Development, Commercialization, Bentracimab Takeda Reports NDA Submission of Lanadelumab to the MHLW as a Preventive Treatment for Hereditary Angioedema Attack in Japan Published: Mar 12, 2021 | Tags: …
PharmaShots Weekly Snapshots (Mar 08 – 12, 2021) Read More »
Sanofi and Translate BIO have begun a clinical trial of their potential mRNA COVID-19 shot, as the French pharma struggles to keep pace with rivals despite its background in vaccines. While Pfizer/BioNTech and Moderna have been able to produce mRNA vaccines in a matter of months Sanofi is considerably behind with its collaboration with Translate …
Sanofi/Translate start clinical trial of mRNA COVID shot Read More »
Eli Lilly and Incyte Report Results of Olumiant (baricitinib) in P-III BRAVE-AA2 Study for Severe Alopecia Areata Published: Mar 5, 2021 | Tags: Eli Lilly and Incyte, Report, Results, Olumiant (baricitinib), P-III, BRAVE-AA2, Study, Severe, Alopecia Areata Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273 in Japan Published: Mar 5, 2021 | Tags: …
PharmaShots Weekly Snapshots (Mar 01 – 05, 2021) Read More »
Eli Lilly’s JAK inhibitor Olumiant has become the first drug in the JAK inhibitor class to be recommended for NHS use in England and Wales as a treatment for atopic dermatitis, also known as eczema. Olumiant (baricitinib) has been backed by cost-effectiveness agency NICE to treat moderate to severe atopic dermatitis in adults who haven’t …
Lilly’s Olumiant is first JAK drug backed by NICE for eczema Read More »
Regeneron Reports IDMC Clearance of Efficacy for REGEN-COV (Casirivimab + Imdevimab) in P-III COVID-19 Outpatient Outcomes Trial Published: Feb 26, 2021 | Tags: Regeneron, Reports, IDMC, Clearance, Efficacy, REGEN-COV (Casirivimab + Imdevimab), P-III, COVID-19, Outpatient, Outcomes, Trial Daiichi Sankyo Collaborates with LYSA-LYSARC-CALYM for Valemetostat in Patients with R/R B-Cell Lymphoma Published: Feb 26, 2021 | …
Shots: The companies collaborated to develop improved tissue-selective AAV vectors to realize effective gene therapy treatments for multiple life-threatening disorders The focus of this agreement is to develop new and modified AAV capsids that exhibit a safe product profile with improved specificity and higher gene delivery efficiency The collaboration comes two years after Sirion signed …
Shots: Health Canada has approved Dupixent for the treatment of mod. to sev. AD in children aged 6 to 11yrs. whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable The approval marks the fifth indication for Dupixent in Canada following the approvals for AD in adults and …
Sanofi’s cancer immunotherapy Libtayo (cemiplimab) has a third US indication after the FDA approved it for certain untreated lung cancer patients. The approval in first-line lung cancer, in non-small cell lung cancer patients whose tumours have high PD-L1 expression brings the drug into competition with Merck & Co’s Keytruda (pembrolizumab), which has become the go-to …
Sanofi’s immunotherapy Libtayo gets FDA not in first line lung cancer Read More »
Shots: The approval is based on the P-III EMPOWER-Lung 1 trial assessing Libtayo (350mg, q3w) monothx. vs platinum doublet CT in 710 patients for the 1L treatment with advanced NSCLC who tested positive for PD-L1 in ≥50% of tumor cells and without EGFR, ALK or ROS1 aberrations The study showed a 32% reduction in the …
Shots: The companies reported the initiation of a P-II dose-finding study assessing the safety, reactogenicity, and immunogenicity of two injections given 21 days apart in 720 adults aged ≥18yrs. The P-II study assesses the potential for refined antigen formulation to achieve an optimal immune response, including in older adults. If P-II results are positive, the …
Sanofi and GlaxoSmithKline are restarting clinical development of their COVID-19 vaccine, which was delayed after hitting a snag late last year. In December interim phase 1/2 trial results showed the vaccine produced a lower immune response in older adults. At the time analysts said that this was likely due to an insufficient concentration of the …
Sanofi/GSK restart COVID-19 vaccine trials after tweaking formulation Read More »
Visby’s POC COVID-19 Test Receives the US FDA’s EUA for Use in CLIA Waived Settings Published: Feb 12, 2020 | Tags: Visby, POC, COVID-19, Test, Receives, US, FDA, EUA, Use, CLIA, Waived, Settings Takeda Collaborates with Ensoma to Accelerate Next-Generation In Vivo Gene Therapies Published: Feb 12, 2020 | Tags: Takeda, Collaborates, Ensoma, Accelerate, Next-Generation, Vivo Gene …
PharmaShots Weekly Snapshots (Feb 08 – 12, 2021) Read More »
The biopharma industry saw numerous deal terminations in 2020. Clinical and regulatory results, change in control limitations, and strategic reprioritizations were among the most common reasons for deal termination. Sanofi and Hanmi’s agreement in 2015 ranked first under which Hanmi regained WW rights to its protein/peptide discovery technology, lapscovery. The second position goes to the …
Top 20 Biopharma Deal Terminations of 2020 Based on Total Deal Value Read More »
Shots: The companies collaborated to investigate oral delivery of Sanofi’s Nanobody based medicines, which are currently available in IV & SC formulations The collaboration will advance the formulation of therapies that are traditionally limited to injections. Nanobodies are the therapeutic proteins based on camelid-derived immunoglobulin single variable domains & have potential to treat multiple diseases …
Sanofi Collaborates with i2O Therapeutics to Evaluate Oral i2O Therapeutics Read More »
Sanofi has said it is to begin manufacturing the COVID-19 shot from Pfizer and BioNTech in a week when supplies are in the spotlight. The French pharma will use its production infrastructure to boost supplies of the vaccine and perform late-stage manufacturing to supply over 125 million doses to the EU. In a statement Sanofi …
Sanofi steps in to boost supplies of Pfizer/BioNTech’s COVID shot Read More »
This year J.P. Morgan 39th Annual Healthcare Conference was conducted virtually and we witnessed multiple announcements from numerous Biopharma companies An analysis of events and catalysts that were announced at the conference during these days are included in the report. Most of the deals occurred in the first two days of the conference Our PharmaShots …
Insights+: Key Deals of JP Morgan Healthcare Conference 2021 Read More »
Life sciences companies are gearing up to enter new markets as they look to secure their positions after a spate of M&A, licensing, and research partnerships in 2020 Artios partnered with Merck with an option to license up to 8 oncology programs proving to be the highest valued deal of 2020 with a total deal …
Top 20 Life Sciences Deals of 2020 by Total Deal Value Read More »
Pharma companies moved fast in 2020 to tackle Covid-19 and to address longstanding issues of racial equity, the CEOS of BD and Sanofi said in a session at the J.P. Morgan Healthcare Conference. The challenge lies in keeping the momentum going in 2021.
Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria Published: Jan 15, 2020 | Tags: Novartis’, Ligelizumab (QGE031), Receives ,US FDA’s, Breakthrough Designation for Patients , Chronic Spontaneous Urticaria Philips Collaborates with Merck KGaA to Advance Personalized Fertility Treatment Published: Jan 15, 2020 | Tags: Philips, Collaborates, Merck KGaA, …
PharmaShots Weekly Snapshots (Jan 11 – 15, 2021) Read More »
The fourth quarter of 2020 contains multiple initiations of clinical trials, big approvals, and numerous deals. COVID-19 related news remains at the peak in this quarter Multiple companies received regulatory bodies’ EUA for their vaccines and treatments for COVID-19. Initiating with, Regeneron sought the US FDA’s EUA for REGN-COV2 Ab combination while Health Canada accelerated …
PharmaShots’ Key Highlights of Fourth Quarter 2020 Read More »
Shots: Biond to receive $125M up front in cash and will be eligible to receive ~$1B+ as development, regulatory & commercial milestones, along with royalties on sales of the therapy Biond will lead P-Ia study of BND-22, assessing its safety & tolerability as a single agent and in combination with approved cancer therapies as well …
Sanofi Signs a License Agreement with Biond for BND-22 Read More »
Sanofi is to acquire UK biotech Kymab in a deal worth up to $1.45 billion as the big French pharma seeks to add to its pipeline of drugs that treat inflammatory diseases and cancer. Cambridge-based Kymab is one of several rising stars on the UK biotech scene, with technology that uses transgenic mice to develop …
Sanofi buys UK’s Kymab and inflammatory disease hopeful for $1.45bn Read More »
Shots: Sanofi to acquire Kymab for $1.1B up front and ~$350M following the achievement of certain milestones. The transaction is expected to be completed in H1’21 The acquisition will add KY1005 to Sanofi’s pipeline and will expedite its presence in the field of immunology Sanofi will get the global rights of KY1005 which is a …
New data means that IL-6 drugs from Roche and Sanofi that had been all-but written off as coronavirus therapies will now be offered routinely to COVID-19 patients in intensive care in the UK. The renaissance of the two therapies comes on the back of the REMAP-CAP trial, which found that the IL-6 inhibitors RoActemra (tocilizumab) …
IL-6 drugs do work in COVID-19, says UK, as it plans NHS use Read More »
Biopharma merger and acquisition activity in 2020 was mainly filled with late-stage, bolt-on acquisitions, which were orders of magnitude smaller than the mega M&A deals of prior years. AstraZeneca holds the top rank by acquiring Alexion Pharmaceuticals among the top 20 acquisitions with a total deal value of $39B at a 1-day premium of 45% …
Top 20 Biopharma M&A of 2020 by Total Deal Value Read More »
“Lockdown’ declared Collins Dictionary word of the year. The year 2020, well known as COVID-19 year has been a busy year for global pharma and biotech companies involved in M&A, option & licensing agreements, and gaining approvals. Our team has compiled a list of 30 most read life sciences news on PharmaShots in 2020. 1. …
2020’s M&A activity hasn’t quite reached the heights of last year’s, where two pharma mega-mergers – BMS’ buyout of Celegne and AbbVie’s acquisition of Allergan – accounted for almost 40% of total M&A deal values. That said, there were still some interesting moves indicating new directions of travel for big pharma players – with most …
UK-based EUSA Pharma has begun a late-stage trial of its antibody siltuximab in COVID-19, hoping that the IL-6 inhibitor will succeed where class rivals from Roche and Sanofi/Regeneron have failed. Hertfordshire-based EUSA said recruitment has begun in phase 3 trial involving patients with COVID-19 previously treated with corticosteroids and other respiratory viruses associated with serious …
EUSA Pharma hopes IL-6 drug will succeed in COVID-19 where rivals failed Read More »
The global generics pharmaceutical market has become an intimidating segment of the pharmaceutical drug market which continuously growing and increasing with its accessibility & benefits offered as efficient and economical drugs. Generics are approved copies of small molecule drugs that contain the same amount of active ingredients, dosage form, safety, strength, route of administration, quality, …
Top 20 Generics Pharma Companies Based On 2019 Revenue Read More »
Sanofi and Regeneron’s Dupixent has had the US market for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) mainly to itself since June 2019, but GlaxoSmithKline’s Nucala is now breathing down its neck. The FDA has started its review of Nucala (mepolizumab) for the inflammatory condition, which results in the growth of nasal polyps …
Sanofi on notice as FDA reviews GSK’s Nucala for nasal polyps Read More »
Richter Acquires Janssen’s Evra Transdermal Contraceptive Patch Assets for $263.5M Published: Dec 3, 2020 | Tags: Asset Purchase Agreement, Evra, Gedeon Richter, Janssen Pharmaceutical, Signs, Transdermal Contraceptive Patch Assets, Treat Jazz Pharma and PharmaMar’s Zepzelca Fail to Meet its Primary Endpoint in P-III ATLANTIS Study for SCLC Published: Dec 3, 2020 | Tags: ATLANTIS, Doxorubicin, …
PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020) Read More »
Eli Lilly and Incyte Receive FDA’s EUA for Baricitinib + Remdesivir to Treat Hospitalized Patients with COVID-19 Published: Nov 20,2020 | Tags: baricitinib, COVID-19, Eli Lilly, Emergency Use Authorization, FDA’s, Incyte, receives, Remdesivir Novartis Signs a License Agreement with Mesoblast to Develop and Commercialize Remestemcel-L for ARDS Published: Nov 20,2020 | Tags: Agreement, ARDS, Commercialize, …
The FDA has agreed to expedite development of two rare disease drugs from Sanofi. The most significant of the two announcements is the Priority Review for avalglucosidase alfa, a potential new therapy for Pompe disease. The review period will be shortened from the standard ten months to six months or less, and the French pharma …
FDA to expedite development of two Sanofi rare disease drugs Read More »
Shots: The approval is based on two P-III studies assessing the safety and efficacy of Supemtek (quadrivalent recombinant influenza vaccine) in 10,000 patients with influenza aged > 18yrs. Supemtek is 1st and only recombinant influenza vaccine approved in the EU The P-III efficacy study demonstrated improved protection against influenza compared to standard-dose influenza vaccine and …
Shots: The US FDA accepted for priority review the BLA of avalglucosidase alfa for long-term enzyme replacement therapy for the treatment of patients with Pompe disease. The target action date for the FDA decision is May 18, 2021 The BLA is based on positive data from two trials: P-III COMET study and P-II mini-COMET study …
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 »
Previously-untreated patients with hepatocellular carcinoma (HCC), a common form of liver cancer, will have an immunotherapy-based treatment option after NICE gave the nod to NHS funding of Roche’s Tecentriq and Avastin combination therapy. The decision by NICE comes shortly after Tecentriq (atezolizumab) and Avastin (bevacizumab) was approved by the European Commission as a first-line treatment …
NICE okays Roche liver cancer immunotherapy, Sanofi’s rare disease drug Read More »
Sanofi’s attempt to take on Roche with a ground-breaking approach to treating haemophilia has hit a setback after the company voluntarily placed its late-stage trials of fitusiran on hold because of safety issues. The news that phase 3 development has been put on hold was not announced by the French pharma, but in a joint …
Sanofi/Alnylan’s haemophilia drug hits another safety speed-bump Read More »
AstraZeneca’s Brilinta (ticagrelor) Receives the US FDA’s Approval to Reduce the Risk of Stroke in Patients with an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack Published: Nov 6, 2020 | Tags: AstraZeneca, Brilinta, ticagrelor, Receives, US FDA, Approval, Acute, High,Risk, Transient, Ischaemic, Stroke Novo Nordisk to Acquire Emisphere Technologies for $1.8B Published: Nov 6, …
Shots: Sanofi to acquire all outstanding shares of Kiadis for $6.34/ share, representing an equity value of $358.76M. The offer price represents a premium of 272% over the closing price on Oct 30, 2020, a premium of ~247% over the 30 trading days VWAP and a premium of ~200% over the 90 trading days VWAP …
Sanofi is to acquire Kiadis, a biotech specialising in therapies based around ‘off the shelf’ natural killer (NK) cells, for 308 million euros ($353 million). The French pharma is buying Kiadis for 5.45 euros per share in cash, an offer price representing a premium of 272% over the biotech’s closing price on Friday evening on …
Sanofi to acquire Kiadis and NK cell tech for $353 million Read More »
Shots: Sanofi will sponsor the clinical trials while MSD will provide KEYTRUDA. Additionally, Sanofi is separately evaluating the activity of THOR-707 in combination with other anti-PD-1 antibodies, including Libtayo (cemiplimab-rwlc) and with anti-EGFR and anti-CD38 antibodies for various types of cancer tumors In preclinical studies, THOR-707 demonstrated the ability to induce the expansion of CD8+T-cells …
The FDA has started a priority review of Regeneron and Sanofi’s checkpoint inhibitor Libtayo in first-line non-small cell lung cancer (NSCLC), based on data they hope will carve out a niche for the drug in a highly-contested market. PD-1 inhibitor Libtayo (cemiplimab) impressed oncologists earlier this year with results from a trial in previously-untreated NSCLC …
FDA sets Feb decision date for Libtayo lung cancer challenge to Keytruda Read More »
The third quarter of 2020 was flooded with major acquisitions in the pharma and biotech industry along with multiple approvals. Starting with the latest acquisitions, Gilead acquired Immunomedics for ~$21B, Illumina acquired GRAIL for ~$8B, J&J acquired Momenta Pharmaceuticals for $6.5B and Nestlé acquired Aimmune Therapeutics for $2.6B, Sanofi acquired Principia Biopharma for ~$3.68B Apart …
PharmaShots’ Key Highlights of Third Quarter 2020 Read More »
Shots: The P-II/III ASCEND trial involves assessing olipudase alfa 3 mg/kg (IV, q2w) vs PBO in 36 adult patients with ASMD type B to evaluate treatment impact on pulmonary function & spleen & liver volume for 52wks. The study demonstrated improvement in lung function (22% vs 3%), reduction in spleen volume (39.5% vs 0.5%), reduction …
Sanofi Presents Results of Olipudase Alfa in Two Clinical Studies at ASHG 2020 Read More »
Akebia Presents Results of Vadadustat in P-lll INNO2VATE Program for Anemia Due to CKD at ASN Kidney Week Published: Oct 23, 2020 | Tags: Akebia, Results, Vadadustat, P-lll, INNO2VATE Global Study, Anemia, Chronic Kidney Disease Sanifit Presents Results of SNF472 for the Treatment of Vascular Calcification at ASN Kidney Week 2020 Published: Oct 22, 2020 …
Immunology is an important branch of science which deals with the study of the immune system. The immune system is a highly regulated and balanced system and when the balance is disturbed, the disease can result. A lot of this work has importance in the development of new therapies and treatments that can handle or …
Top 20 Immunology Companies Based 2019 Immunology Segment Revenue Read More »
French biotech SparingVision has raised 44.5 million euros ($52.7 million) to develop its gene therapy for a rare ocular disease. The round was led by 4BIO Capital and UPMC Enterprises with Jeito Capital and Ysios Capital joining. Current investors Bpifrance and Foundation Fighting Blindness also participated. In a statement, the company said funds will be …
SparingVision raises €44.5m for retinitis pigmentosa gene therapy Read More »
Shots: The NICE has issued FAD which is based on the P-III ICARIA-MM trial assessing isatuximab + pom-dex vs pom-dex in patients prior treated with 3L treatment and at least 2L therapies including lenalidomide and a proteasome inhibitor with RRMM in 307 patients with RRMM The study demonstrated that the combination regimen demonstrated a reduction …
Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease Published: Oct 15, 2020 | Tags: approval, Canada, health, Inherited Retinal Disease, Luxturna, Novartis, receives, voretigene neparvovec Galapagos & Servier’s GLPG1972/S201086 Fails to Meet its Primary Endpoint in P-II ROCCELLA Study for Knee Osteoarthritis Published: Oct 15, …
Shots: The companies reported the preclinical results of MRT5500 demonstrating the potential of the vaccine in neutralizing the Abs against SARS-CoV-2. The two doses of MRT5500 induced neutralizing antibody levels significantly higher than those observed in COVID-19 patients The preclinical data support the advancement of MRT5500 for clinical development. The companies anticipate the initiation of …
Sanofi and Translate Bio to Advance MRT5500 into Clinical Study Against COVID-19 Read More »
Sanofi will shortly start human trials of a second coronavirus vaccine, developed with US biotech Translate Bio, after reporting that it stimulated antibodies against SARS-CoV-2 in preclinical testing. The French drugmaker’s Sanofi Pasteur vaccines division says it is planning a phase 1/2 trial of the mRNA-based vaccine, called MRT5500, before the end of the year. …
Sanofi preps trials of second COVID-19 shot, as Russia approves another Read More »
Sobi & Selecta Report Results of SEL-212 in P-II COMPARE Study for Chronic Refractory Gout Published: Oct 1, 2020 | Tags: Chronic Refractory Gout, COMPARE Study, Important Clinical Improvement, P-II, patients, reports, results, SEL-212, Selecta Biosciences, Sobi 2. Moderna’s mRNA-1273 COVID-19 Vaccine Demonstrate Immune Responses in Older Adults Published: Oct 1, 2020 | Tags: COVID-19, …
PharmaShots Weekly Snapshot (Sept 28 – Oct 1, 2020) Read More »
Darlene Dobry, Strategic Advisor, Medical Devices and Pharmaceuticals As the COVID-19 pandemic continues to bring the world’s economies, healthcare systems, and communities to their knees, the Pharma industry appears to be the shining hope to help us return to a new normal. Could the industry’s response to this global public health crisis be the Rx …
Is COVID the Rx for the Pharmaceutical Industry’s Reputation? Read More »
1. BioMarin Reports NDA Submission to the US FDA for Vosoritide to Treat Children with Achondroplasia Published: Aug 20, 2020 | Tags: BioMarin, Reports, NDA, Submission, US, FDA, Vosoritide, Children, Achondroplasia 2. Junshi and Impact to Establish Joint Venture for Senaparib (IMP4297) in China Published: Aug 20, 2020 | Tags: Junshi, Impact, Establish, Joint Venture, …
It’s mission accomplished for Novartis after the FDA approved ofatumumab for multiple sclerosis, completing a project where the former cancer drug has been repurposed. The FDA approved ofatumumab under the brand name Kesimpta for people living with relapsing forms of multiple sclerosis. Kesimpta will have a list price of around $83,000 a year, which the …
Mission successful for Novartis after FDA approves ofatumumab in MS Read More »
Shots: The Health Canada has approved a new indication as an add-on maintenance treatment with intranasal corticosteroids in patients with CRSwNP, inadequately controlled by systemic corticosteroids or surgery The approval is based on P-III studies (24wks. SINUS-24 and 52wks. SINUS-52) assessing Dupixent (300mg, q2w) + SOC intranasal corticosteroids vs PBO + intranasal corticosteroids. The studies …
New strategy, new outlook: Sanofi takes another step, gains full control over the Principia’s MS treatment Sanofi has inked a definitive agreement with Principia Biopharma to acquire the company, all of its outstanding shares, and its BTK inhibitors in a deal worth USD 3.68 Billion. The deal is expected to complete in the fourth quarter …
The French drugmaker will take full control of SAR442168, a BTK inhibitor developed for multiple sclerosis that it in-licensed from the California biotech company in 2017.
Shots: Sanofi to acquire Principia Biopharma in an all-stock transaction, at $100/share making total deal value ~$3.68B in cash. The transaction is expected to be completed in Q4’20 The focus of the acquisition is to strengthen its R&D areas of autoimmune and allergic diseases with the expansion of the SAR442168 development program into CNS disorders. …
Sanofi to Acquire Principia Biopharma for ~$3.68B Read More »
Sanofi is to buy Principia Biopharma for up to $3.68 billion, adding a potential multiple sclerosis drug to its pipeline. The French pharma said it will pay $100 per share in cash for San Francisco-based Principia, which specialises in Bruton’s kinase (BTK) inhibitor drugs, after the deal was unanimously agreed by both boards of directors. …
Sanofi adds BTK inhibitors to pipeline with $3.68bn Principia Biopharma acquisition Read More »
1. Roche’s Evrysdi (risdiplam) Receives the US FDA’s Approval for SMA in Adults and Children Published: Aug 10, 2020 | Tags: Roche, Evrysdi, risdiplam, Receives, US, FDA, Approval, SMA, Adults, Children 2. The US FDA Approves Guardant360 CDx as the First Liquid Biopsy NGS Assay to Identify EGFR Mutations in Non-Small Cell Lung Cancer Published: Aug 07, …
What You Should Know: – Ginger announces $50 Million in Series D funding to expand access to its on-demand mental healthcare system led by Advance Venture Partners and Bessemer Venture Partners; joined by Cigna Ventures and existing investors. – Company has more than tripled revenue over the past year, now brings access to on-demand mental …
Ginger Lands $50M to Expand On-Demand Mental Health Support Platform Read More »
Sanofi has been placed under formal investigation in France for possible charges including manslaughter relating to the epilepsy drug Depakine, following the deaths of four babies whose mothers took the drug. Depakine was found to carry a high risk of birth defects if taken by pregnant women. Sanofi, which denies wrongdoing and says it warned …
Sanofi faces possible manslaughter charges in epilepsy drug probe Read More »
Shots: The US government will provide ~$2.1B to support the development of the vaccine, including clinical trials with some amount to be used for ramping up the manufacturing and delivery of an initial 100M dose of the vaccine The US government has an option to supply an additional 500M dose and helps the government’s Operation …
1. Oxford Biomedica Signs Three Year Clinical Supply Agreement with Axovant to Manufacture and Supply AXO-Lenti-PD for Parkinson’s Disease Published: Jul 31, 2020 | Tags: Oxford Biomedica, Signs, Three Year, Clinical Supply Agreement, Axovant, Manufacture, Supply, AXO-Lenti-PD, Parkinson’s Disease 2. Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against COVID-19 in the US and Belgium …
The US government has selected a potential vaccine from Sanofi and GlaxoSmithKline for its Operation Warp Speed COVID-19 vaccine development initiative, committing up to $2.1 billion for an initial 100 million doses. The collaborative effort with the US government will accelerate the development and manufacturing of a COVID-19 recombinant protein-based vaccine. Developed by Sanofi in …
US pays $2.1bn to Sanofi/GSK for 100 million doses of COVID-19 vaccine Read More »
Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected …
Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – July 2020 Read More »
The companies will provide 100 million doses of their jointly developed vaccine. But with a Phase I/II study planned in September, it is behind in development compared with those of Moderna and Pfizer and BioNTech, which have already started late-stage clinical testing.
Shots: The two global companies will supply up to ~60M doses of a vaccine to the UK’s government to combat COVID-19 Sanofi leads the clinical development and registration of the vaccine and expects a P-I/II study to be initiated in Sept’2020, followed by a P-III study by the end of 2020. Additionally, the companies are …
The UK government has signed its fourth coronavirus vaccine deal, snapping up 60 million doses of an experimental shot being developed by Sanofi and GlaxoSmithKline. The order has come in even before the vaccine has started clinical development, with a phase 1/2 trial not due to get underway until September. Sanofi is providing the vaccine …
UK places order for 60m doses of Sanofi/GSK’s COVID-19 vaccine Read More »
Belgium’s ExeVir Bio is to accelerate development of a new treatment for COVID-19 based on llama antibodies, after a 23 million euro ($27 million) financing round. ExeVir is a spin-out of Vlaams Instituut voor Biotechnologie (VIB), Belgium’s life sciences research institute and the company also has backing from UCB Ventures, and specialist European life sciences …
Can llama antibodies beat COVID-19? Belgium’s ExeVir raises 23m euros to find out Read More »
1. Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis Published: Jul 24, 2020 | Tags: Gilead, Galapagos, Jyseleca, filgotinib, Receive, CHMP, Positive Opinion, Moderate, Severe, Rheumatoid Arthritis 2. Synaffix Expands its Existing Collaboration with ADC Therapeutics to Explore Two Additional Programs Published: Jul 24, 2020 | Tags: Synaffix, Expands, …
1. Eli Lilly Reports Results of Mirikizumab in P-III OASIS-2 Study to Treat Moderate to Severe Plaque Psoriasis Published: Jul 17, 2020 | Tags: Eli Lilly, Reports, Results, Mirikizumab, P-III, OASIS-2, Study, Treat, Moderate, Severe, Plaque Psoriasis 2. Oncorus Initiates P-I Study of ONCR-177 in Patients with Advanced / Refractory Cutaneous Subcutaneous or Metastatic Nodal Solid …
Sanofi is to begin preparations in autumn to spin off its active ingredients business and is lining up a potential stock market launch by 2022, according to a press report. Citing sources close to the company Reuters noted that the spin-off is part of a plan to boost profits announced by new CEO Paul Hudson in December. Hudson joined the company …
Sanofi set to spin off API business late next year – report Read More »
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