Sanofi

Sanofi’s Dupixent (dupilumab) Receives NICE Recommendation for the Treatment of Severe Asthma

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 …

Sanofi’s Dupixent (dupilumab) Receives NICE Recommendation for the Treatment of Severe Asthma Read More »

NICE changes stance on Sanofi’s Dupixent for severe asthma

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 »

PharmaShots Weekly Snapshots (October 11 – 15, 2021)

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

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

Sanofi’s Sarclisa Combination Regimen Receives Health Canada’s Approval for Multiple Myeloma

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 …

Sanofi’s Sarclisa Combination Regimen Receives Health Canada’s Approval for Multiple Myeloma Read More »

Sanofi Presents Results of Tolebrutinib in a P-IIb LTS for Relapsing Forms of Multiple Sclerosis at ECTRIMS 2021

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); …

Sanofi Presents Results of Tolebrutinib in a P-IIb LTS for Relapsing Forms of Multiple Sclerosis at ECTRIMS 2021 Read More »

Actemra shortage spills over to include Sanofi’s rival Kevzara

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 »

Sanofi Signs a Non-Exclusive Clinical Collaboration Agreement with Mirati to Evaluate Adagrasib + SAR442720 (RMC-4630) in P-I/II Study for KRAS G12C-Mutated Lung Cancer

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 …

Sanofi Signs a Non-Exclusive Clinical Collaboration Agreement with Mirati to Evaluate Adagrasib + SAR442720 (RMC-4630) in P-I/II Study for KRAS G12C-Mutated Lung Cancer Read More »

Sanofi Reports Interim Results of Fluzone High-Dose Quadrivalent Vaccine + COVID-19 mRNA Booster Dose in First Descriptive Study for COVID-19

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 …

Sanofi Reports Interim Results of Fluzone High-Dose Quadrivalent Vaccine + COVID-19 mRNA Booster Dose in First Descriptive Study for COVID-19 Read More »

Sanofi Presents Results of Amlitelimab (KY1005) in P-IIa Study for the Treatment of Moderate-To-Severe Atopic Dermatitis at EADV 2021

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 …

Sanofi Presents Results of Amlitelimab (KY1005) in P-IIa Study for the Treatment of Moderate-To-Severe Atopic Dermatitis at EADV 2021 Read More »

Key drug in Sanofi’s $1.45bn Kymab buyout shows promise in eczema

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 »

PharmaShots’ Key Highlights of Third Quarter 2021

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, …

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Sanofi abandons mRNA COVID jab, despite positive trial

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 »

PharmaShots Weekly Snapshots (September 20 – 24, 2021)

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 »

ESMO21: Libtayo extends survival in first-line NSCLC, challenging Keytruda

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 »

Insights+: The US FDA New Drug Approvals in August 2021

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 »

Sanofi Provides Update on P-III PEGASUS Trial of Rilzabrutinib for the Treatment of Pemphigus

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 …

Sanofi Provides Update on P-III PEGASUS Trial of Rilzabrutinib for the Treatment of Pemphigus Read More »

Sanofi snaps up Kadmon and its transplant drug Rezurock

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 »

PharmaShots Weekly Snapshots (August 30 – September 03, 2021)

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 »

PharmaShots Weekly Snapshots (August 30 – September 03, 2021)

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 »

Insights+ Key Biosimilars Events of August 2021

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 …

Insights+ Key Biosimilars Events of August 2021 Read More »

Sanofi and Regeneron’s Dupixent Meets All Endpoints in P-III Study in Children with Atopic Dermatitis

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 …

Sanofi and Regeneron’s Dupixent Meets All Endpoints in P-III Study in Children with Atopic Dermatitis Read More »

Top 7 Pharma Industry Leaders in 2020 By the Numbers

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 »

Insights+: The US FDA New Drug Approvals in July 2021

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 »

Look out Dupixent, Lilly’s lebrikizumab is on the march

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 »

PharmaShots Weekly Snapshots (Aug 09 – 13, 2021)

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 »

Top 20 Immunology Companies Based on 2020 Immunology Segment Revenue

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 extends its Pompe range with first Nexviazyme OK

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 »

PharmaShots Weekly Snapshots (Aug 02 – 06, 2021)

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, Regeneron eye Libtayo challenge to Keytruda in first-line lung cancer

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’s mRNA strategy adds biggest piece yet with $3.2B Translate Bio buyout

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 swoops on partner Translate, buying the mRNA firm for $3.2bn

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 »

Sanofi to Acquire Translate Bio for ~$3.2B

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 …

Sanofi to Acquire Translate Bio for ~$3.2B Read More »

PharmaShots Weekly Snapshots (July 26 – 30, 2021)

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 »

FDA okays Mylan insulin drug as first ‘interchangeable’ biosimilar

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 »

Regeneron and Sanofi Report Results of Dupixent (dupilumab) in P-III LIBERTY CUPID Clinical Program for Chronic Spontaneous Urticaria

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 …

Regeneron and Sanofi Report Results of Dupixent (dupilumab) in P-III LIBERTY CUPID Clinical Program for Chronic Spontaneous Urticaria Read More »

Sanofi’s Avalglucosidase alfa Receives CHMP’s Positive Opinion for Patients with Pompe Disease

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 …

Sanofi’s Avalglucosidase alfa Receives CHMP’s Positive Opinion for Patients with Pompe Disease Read More »

Pfizer puts up $1bn to buy into Arvinas breast cancer programme

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 »

EMA starts review of latecomer GSK/Sanofi COVID-19 vaccine

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 »

PharmaShots Weekly Snapshots (July 05 – 09, 2021)

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 »

Sanofi Signs ~$1B Agreement with Eureka & MSK for their Multiple Myeloma Candidate

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 »

PharmaShots’ Key Highlights of Second Quarter 2021

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 »

PharmaShots Weekly Snapshots (June 14 – 18, 2021)

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 »

CytoReason Collaborates with Sanofi to Initiate its Project Utilizing AI Technology for Asthma

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 …

CytoReason Collaborates with Sanofi to Initiate its Project Utilizing AI Technology for Asthma Read More »

Sanofi Presents Results of Sutimlimab in P-III CADENZA Trial to Treat Hemolysis Patients with Cold Agglutinin Disease at EHA 2021

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 Presents Results of Sutimlimab in P-III CADENZA Trial to Treat Hemolysis Patients with Cold Agglutinin Disease at EHA 2021 Read More »

EHA21: Sanofi builds case for rare disease drug sutimlimab after FDA rejection

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 »

Experts discuss the field force’s customer-centric future

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 »

PharmaShots Weekly Snapshots (May 31 – June 4, 2021)

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 pays Kyowa $400m upfront for OX40 eczema drug

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 »

Sanofi’s venglustat bombs again, but isn’t dead yet

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 »

Sanofi Stops the P-II/III STAGED-PKD Study of Venglustat for Autosomal Dominant Polycystic Kidney Disease

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 …

Sanofi Stops the P-II/III STAGED-PKD Study of Venglustat for Autosomal Dominant Polycystic Kidney Disease Read More »

PharmaShots Weekly Snapshots (May 24 – 28, 2021)

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 »

GSK, Sanofi eye Q4 approval as COVID jab starts phase 3

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 »

Sanofi and GSK Initiate P-III Clinical Study of their COVID-19 Vaccine

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 »

After Sanofi’s setbacks, Takeda eyes finish line with its dengue vaccine

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 »

PharmaShots Weekly Snapshots (May 17 – 21, 2021)

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 »

Regeneron and Sanofi Present Results of Dupixent (dupilumab) in P-III VOYAGE Study for Asthma at ATS 2021

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 …

Regeneron and Sanofi Present Results of Dupixent (dupilumab) in P-III VOYAGE Study for Asthma at ATS 2021 Read More »

Sanofi & GSK Covid-19 vaccine posts strong clinical data, paves way for Phase 3

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.

Arecor hopes London stock market float will raise profile of insulin products

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/GSK move latecomer COVID-19 shot into phase 3

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 »

Sanofi and GSK Report Results of its COVID-19 Vaccine in a P-II Study Across All Adult Age Groups

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 & …

Sanofi and GSK Report Results of its COVID-19 Vaccine in a P-II Study Across All Adult Age Groups Read More »

PharmaShots Weekly Snapshots (May 10 – 14, 2021)

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 »

Regeneron and Sanofi Present Positive Results of Libtayo (cemiplimab) from P-III Trial for Cervical Cancer at ESMO2021

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, …

Regeneron and Sanofi Present Positive Results of Libtayo (cemiplimab) from P-III Trial for Cervical Cancer at ESMO2021 Read More »

Cellectis Collaborates with Sanofi for Alemtuzumab to be Utilized in CART-Cell Trials

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 »

PharmaShots Weekly Snapshots (May 03 – 07, 2021)

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 »

Sanofi Signs a Three-Year Collaboration with Stanford Medicine to Accelerate Immunology Research

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 Signs a Three-Year Collaboration with Stanford Medicine to Accelerate Immunology Research Read More »

Sanofi begins three-year immunology R&D tie-up with Stanford

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 eyes 2022 filing for haemophilia drug fitusiran, despite safety issue

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 »

Sanofi and AstraZeneca Report Results of Nirsevimab in P-III MELODY Study for the Protection of Healthy Infants Against Respiratory Syncytial Virus Disease

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 …

Sanofi and AstraZeneca Report Results of Nirsevimab in P-III MELODY Study for the Protection of Healthy Infants Against Respiratory Syncytial Virus Disease Read More »

PharmaShots Weekly Snapshots (Apr 19 – 23, 2021)

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 »

PharmaShots’ Key Highlights of First Quarter 2021

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 »

Sanofi’s Sarclisa (isatuximab) Receives EC’s Approval for Adults with Relapsed and Refractory Multiple Myeloma

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 …

Sanofi’s Sarclisa (isatuximab) Receives EC’s Approval for Adults with Relapsed and Refractory Multiple Myeloma Read More »

PharmaShots Weekly Snapshots (Apr 12 – 16, 2021)

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 »

Sanofi Collaborates with C4XD for an Oral Therapy to Treat Inflammatory Diseases

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 »

Scotland opens door to Translarna for Duchenne muscular dystrophy

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 licences in potential oral IL-17 drug from UK’s C4X Discovery

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 »

Sanofi to Acquire Tidal Therapeutics for ~$470M

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 to Acquire Tidal Therapeutics for ~$470M Read More »

Top 20 BioPharma Companies based on 2020 Total Revenue

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

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

PharmaShots Weekly Snapshots (Mar 29 – Apr 02, 2021)

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 »

Sanofi’s Sarclisa (isatuximab-irfc) + Carfilzomib and Dexamethasone Receives the US FDA’s Approval for the Treatment of R/R Multiple Myeloma

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 …

Sanofi’s Sarclisa (isatuximab-irfc) + Carfilzomib and Dexamethasone Receives the US FDA’s Approval for the Treatment of R/R Multiple Myeloma Read More »

Sanofi’s Sarclisa gains new US multiple myeloma indication

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 »

PharmaShots Weekly Snapshots (Mar 15 – 19, 2021)

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 »

PharmaShots Weekly Snapshots (Mar 15 – 19, 2021)

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 »

Global Blood Therapeutics inks deal for two sickle cell disease drugs from Sanofi

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, Regeneron prep filings for Libtayo in cervical cancer

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 »

Regeneron and Sanofi Report Results of Libtayo (cemiplimab) in P-III Trial for Cervical Cancer

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, …

Regeneron and Sanofi Report Results of Libtayo (cemiplimab) in P-III Trial for Cervical Cancer Read More »

PharmaShots Weekly Snapshots (Mar 08 – 12, 2021)

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/Translate start clinical trial of mRNA COVID shot

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 »

PharmaShots Weekly Snapshots (Mar 01 – 05, 2021)

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 »

Lilly’s Olumiant is first JAK drug backed by NICE for eczema

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 »

PharmaShots Weekly Snapshots (Feb 22- 26, 2021)

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 | …

PharmaShots Weekly Snapshots (Feb 22- 26, 2021) Read More »

Sanofi Collaborates with Sirion to Develop Gene Therapy Treatment with Improved AAV Capsids

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 …

Sanofi Collaborates with Sirion to Develop Gene Therapy Treatment with Improved AAV Capsids Read More »

Sanofi’s Dupixent (dupilumab) Receives Health Canada Approval as the First Biologic to Treat Atopic Dermatitis in Children

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 Dupixent (dupilumab) Receives Health Canada Approval as the First Biologic to Treat Atopic Dermatitis in Children Read More »

Sanofi’s immunotherapy Libtayo gets FDA not in first line lung cancer

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 »

Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) Receive the US FDA’s Approval as 1L Treatment for Advanced NSCLC

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 …

Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) Receive the US FDA’s Approval as 1L Treatment for Advanced NSCLC Read More »

Sanofi and GSK Initiate P-II Study of their Adjuvanted Recombinant Protein-Based COVID-19 Vaccine

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 GSK Initiate P-II Study of their Adjuvanted Recombinant Protein-Based COVID-19 Vaccine Read More »

Sanofi/GSK restart COVID-19 vaccine trials after tweaking formulation

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 »

PharmaShots Weekly Snapshots (Feb 08 – 12, 2021)

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 »

Top 20 Biopharma Deal Terminations of 2020 Based on Total Deal Value

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 »

Sanofi Collaborates with i2O Therapeutics to Evaluate Oral i2O Therapeutics

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 steps in to boost supplies of Pfizer/BioNTech’s COVID shot

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 »

Insights+: Key Deals of JP Morgan Healthcare Conference 2021

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 »

Top 20 Life Sciences Deals of 2020 by Total Deal Value

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 »

PharmaShots Weekly Snapshots (Jan 11 – 15, 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 »

PharmaShots’ Key Highlights of Fourth Quarter 2020

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 »

Sanofi Signs a License Agreement with Biond for BND-22

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 buys UK’s Kymab and inflammatory disease hopeful for $1.45bn

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 »

IL-6 drugs do work in COVID-19, says UK, as it plans NHS use

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 »

Top 20 Biopharma M&A of 2020 by Total Deal Value

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 »

PharmaShots’ Most Read News of 2020

“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. …

PharmaShots’ Most Read News of 2020 Read More »

The top 5 pharma M&A deals of 2020

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 …

The top 5 pharma M&A deals of 2020 Read More »

EUSA Pharma hopes IL-6 drug will succeed in COVID-19 where rivals failed

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 »

Top 20 Generics Pharma Companies Based On 2019 Revenue

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 on notice as FDA reviews GSK’s Nucala for nasal polyps

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 »

PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020)

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 »

PharmaShots Weekly Snapshot (Nov 16-20, 2020)

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, …

PharmaShots Weekly Snapshot (Nov 16-20, 2020) Read More »

FDA to expedite development of two Sanofi rare disease drugs

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 »

Sanofi’s Supemtek (quadrivalent recombinant influenza vaccine) Receives the EC’s Approval to Prevent Influenza

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 …

Sanofi’s Supemtek (quadrivalent recombinant influenza vaccine) Receives the EC’s Approval to Prevent Influenza Read More »

Sanofi’s Avalglucosidase alfa Receives US FDA’s Priority Review as Enzyme Replacement Therapy for Pompe Disease

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 …

Sanofi’s Avalglucosidase alfa Receives US FDA’s Priority Review as Enzyme Replacement Therapy for Pompe Disease Read More »

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

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

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

NICE okays Roche liver cancer immunotherapy, Sanofi’s rare disease drug

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 …

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Sanofi/Alnylan’s haemophilia drug hits another safety speed-bump

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 »

PharmaShots Weekly Snapshot (Nov 02-06, 2020)

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, …

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Sanofi to acquire Kiadis and NK cell tech for $353 million

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 »

Sanofi Entered into an Agreement with Merck to Conduct a P-II Study of THOR-707 in Sequenced Administration with MSD’s KEYTRUDA® (pembrolizumab) in Patients with Various Cancers

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 …

Sanofi Entered into an Agreement with Merck to Conduct a P-II Study of THOR-707 in Sequenced Administration with MSD’s KEYTRUDA® (pembrolizumab) in Patients with Various Cancers Read More »

FDA sets Feb decision date for Libtayo lung cancer challenge to Keytruda

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 »

PharmaShots’ Key Highlights of Third Quarter 2020

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 …

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Sanofi Presents Results of Olipudase Alfa in Two Clinical Studies at ASHG 2020

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 »

PharmaShots Weekly Snapshot (Oct 19 – 23, 2020)

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 …

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Top 20 Immunology Companies Based 2019 Immunology Segment Revenue

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 …

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SparingVision raises €44.5m for retinitis pigmentosa gene therapy

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 …

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Sanofi’s Sarclisa (isatuximab) Receives NICE Recommendation for Patients with Multiple Myeloma

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 …

Sanofi’s Sarclisa (isatuximab) Receives NICE Recommendation for Patients with Multiple Myeloma Read More »

PharmaShots Weekly Snapshot (Oct 12-16, 2020)

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, …

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Sanofi and Translate Bio to Advance MRT5500 into Clinical Study Against COVID-19

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 …

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Sanofi preps trials of second COVID-19 shot, as Russia approves another

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 »

PharmaShots Weekly Snapshot (Sept 28 – Oct 1, 2020)

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, …

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Is COVID the Rx for the Pharmaceutical Industry’s Reputation?

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 »

PharmaShots Weekly Snapshot (Aug 17 -21 2020)

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, …

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Mission successful for Novartis after FDA approves ofatumumab in MS

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 …

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Sanofi’s Dupixent (dupilumab) Receives the Health Canada Approval for Severe Chronic Rhinosinusitis with Nasal Polyposis

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 …

Sanofi’s Dupixent (dupilumab) Receives the Health Canada Approval for Severe Chronic Rhinosinusitis with Nasal Polyposis Read More »

Sanofi acquires Principia; FDA’s Nod to Roche’s Enspryng; BMS, Dragonfly’s Licensing Deal

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 …

Sanofi acquires Principia; FDA’s Nod to Roche’s Enspryng; BMS, Dragonfly’s Licensing Deal Read More »

Sanofi to Acquire Principia Biopharma for ~$3.68B

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 adds BTK inhibitors to pipeline with $3.68bn Principia Biopharma acquisition

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 »

PharmaShots Weekly Snapshot (Aug 10 – 14, 2020)

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, …

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Ginger Lands $50M to Expand On-Demand Mental Health Support Platform

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 …

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Sanofi faces possible manslaughter charges in epilepsy drug probe

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 …

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Sanofi and GSK Receive $2.1B from the US Government to Supply 100M Doses of COVID-19 Vaccine

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 …

Sanofi and GSK Receive $2.1B from the US Government to Supply 100M Doses of COVID-19 Vaccine Read More »

PharmaShots Weekly Snapshot (Jul 27- 31, 2020)

 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 …

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US pays $2.1bn to Sanofi/GSK for 100 million doses of COVID-19 vaccine

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 …

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Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – July 2020

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 »

Sanofi, GSK nab $2.1B deal from federal government to provide Covid-19 vaccine

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.

Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M Doses of COVID-19 Vaccine

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 …

Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M Doses of COVID-19 Vaccine Read More »

UK places order for 60m doses of Sanofi/GSK’s COVID-19 vaccine

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 »

Can llama antibodies beat COVID-19? Belgium’s ExeVir raises 23m euros to find out

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 »

PharmaShots Weekly Snapshot (Jul 20- 24, 2020)

 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, …

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PharmaShots Weekly Snapshot (Jul 13- 17, 2020)

 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 …

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Sanofi set to spin off API business late next year – report

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 »