Roche

FDA OKs first biosimilar of Roche’s blockbuster AMD drug Lucentis

Samsung Bioepis and Biogen have claimed the first FDA approval for a biosimilar version of Roche and Novartis’ Lucentis (ranibizumab) for leading causes of blindness, raising the prospect of a cheaper treatment option for US patients. The US green light for Byooviz (formerly SB11) covers the treatment of wet age-related macular degeneration (AMD) and two …

FDA OKs first biosimilar of Roche’s blockbuster AMD drug Lucentis Read More »

ESMO21: Enhertu brings it’s A game to second-line breast cancer

AstraZeneca and Daiichi Sankyo were clearly excited by data from a trial pitting their HER2 antibody-drug conjugate (ADC) Enhertu against Roche’s rival Kadcyla when they reported top-line results last month – and a look at the full data set reveals why. In the DESTINY-Breast03 trial, Enhertu (trastuzumab deruxtecan) reduced the risk of disease progression or …

ESMO21: Enhertu brings it’s A game to second-line breast cancer Read More »

ESMO21: Roche’s giredestrant takes stage in battle of the oral SERDs

Roche has revealed the first phase 2 clinical data with giredestrant, one of a clutch of new selective oestrogen receptor degraders (SERDs) hoping to provide an oral alternative to AstraZeneca’s injectable Faslodex for breast cancer. The Swiss drugmaker presented results from its coopERA trial of giredestrant in post-menopausal women with hormone receptor (HR)-positive, HER2-negative early …

ESMO21: Roche’s giredestrant takes stage in battle of the oral SERDs Read More »

Roche Collaborates with Temedica to Launch Brisa App for the Treatment of Multiple Sclerosis

Shots: The companies collaborated to launch a digital companion app i.e., Brisa to treat patients with MS. The app will be offered free of charge for users and motivates to change lifestyle in the long term The Brisa app is designed as an individual digital companion & will collect daily health data like activity, sleep, …

Roche Collaborates with Temedica to Launch Brisa App for the Treatment of Multiple Sclerosis Read More »

Roche to Acquire TIB Molbiol for Bolstering its Molecular Diagnostics Portfolio

Shots: Roche has signed a purchase agreement to acquire 100% of the outstanding shares of the TIB. The transaction is expected to close in Q4’21 The acquisition will bolster Roche’s PCR test portfolio of molecular diagnostics solutions with the addition of multiple assays for infectious disease TIB Molbiol currently has 45+ CE-IVD marked tests and …

Roche to Acquire TIB Molbiol for Bolstering its Molecular Diagnostics Portfolio Read More »

Roche inks $3B deal; Owlstone raises $58M; FDA approves OCS heart system; Google, Mayo Clinic build brain-mapping AI algorithm

Roche’s Genentech taps Adaptimmune for T-Cell Therapy Collaboration for USD 3 Billion A collaboration valued more than USD 3 billion, Genentech, a member of the Roche Group, declared it will collaborate with Adaptimmune for developing and commercializing allogeneic T-cell therapies to treat multiple cancer indications.  Under their deal Genentech will work with Adaptimmune to develop …

Roche inks $3B deal; Owlstone raises $58M; FDA approves OCS heart system; Google, Mayo Clinic build brain-mapping AI algorithm Read More »

Roche bets $300M on Adaptimmune tech for off-the-shelf cell therapies for cancer

Roche is partnering with Adaptimmune Therapeutics to develop allogeneic cell therapies based on Adaptimmune’s technology. In addition to these “off-the-shelf” products, the partners will also develop a personalized allogeneic cell therapy designed specifically for a patient’s cancer.

Roche dives further into cancer cell therapy with Adaptimmune deal

Roche has largely been a spectator on the side lines as other drugmakers have embraced cell therapies for cancer, but it has made a big play now, pledging $150 million upfront to an alliance with Adaptimmune Therapeutics. The Swiss drugmaker is backloading the five-year deal with around $3 billion in milestones, as the two companies …

Roche dives further into cancer cell therapy with Adaptimmune deal Read More »

AC Immune claims half a win for tau drug in Alzheimer’s trial

Shares in AC Immune leaped today after the company said its tau-targeting Alzheimer’s disease candidate semorinemab hit one of its objectives in a phase 2 trial, although it missed another. The Swiss biotech’s Nasdaq-listed shares were up around 66% shortly after the announcement of data from the LAURIET study in patients with mild-to-moderate Alzheimer’s disease, …

AC Immune claims half a win for tau drug in Alzheimer’s trial Read More »

PharmaShots Weekly Snapshots (August 23 – 27, 2021)

Ascendis’ Skytrofa (lonapegsomatropin-tcgd) Receives the US FDA’s Approval for Pediatric Growth Hormone Deficiency Published: Aug 27, 2021 | Tags: Ascendis, Skytrofa, lonapegsomatropin-tcgd, US, FDA, Approval, Pediatric Growth Hormone Deficiency Amgen Presents Results of Repatha (evolocumab) in P-III HUYGENS Study for the Treatment of Acute Coronary Syndrome at ESC 2021 Published: Aug 27, 2021 | Tags: …

PharmaShots Weekly Snapshots (August 23 – 27, 2021) 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 »

Roche Signs a License Agreement with Shape to Advance AAV-based RNA Editing Technology for Neuroscience and Rare Disease

Shots: Shape is eligible to receive $3B+ including initial payment, development, regulatory, and sales milestone along with royalties on sales of therapies resulting from the collaboration The collaboration will utilize Shape’s RNA editing platform i.e., RNAfix and AAVid for next-generation tissue-specific AAVs to develop gene therapy for AD, PD & rare diseases Shape to conduct …

Roche Signs a License Agreement with Shape to Advance AAV-based RNA Editing Technology for Neuroscience and Rare Disease Read More »

Europe has its first Lucentis biosimilar, Samsung Bioepis’ Byooviz

Novartis and Roche’s big-selling eye drug Lucentis has its first biosimilar competitor in Europe, after the European Commission approved Samsung Bioepis’ copycat drug Byooviz. Byooviz (ranibizumab, also known as SB11) has been cleared for the same indications as Lucentis – including namely wet age-related macular degeneration (AMD) and diabetic macular oedema (DMO – and will …

Europe has its first Lucentis biosimilar, Samsung Bioepis’ Byooviz Read More »

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

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

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

Roche’s Ventana MMR RxDx Panel Test Receives the US FDA’s Approval as First CDx to Detect dMMR Solid Tumor

Shots: The FDA has approved the Ventana MMR RxDx Panel test as a CDx to identify patients with dMMR advanced solid tumors, who may be eligible for Jemperli monothx., based on the results of the MMR biomarker test Ventana MMR RxDx Panel provides access to clinicians with fully automated panel of MMR biomarkers tested by …

Roche’s Ventana MMR RxDx Panel Test Receives the US FDA’s Approval as First CDx to Detect dMMR Solid Tumor Read More »

PROVENT trial puts AZ COVID antibody combo back on track

AstraZeneca’s AZD7442 has shown that it can prevent COVID-19 infection when given to healthy patients – the first time this has been demonstrated by a long-acting antibody-based drug. The results of the almost 5,200-patient PROVENT study show that pre-exposure prophylaxis using the antibody combination reduced the risk of developing symptomatic COVID-19 by 77% compared to …

PROVENT trial puts AZ COVID antibody combo back on track Read More »

Amid Actemra shortage, WHO asks Roche to ensure equitable access

Roche’s arthritis drug Actemra has become a key treatment for people with severe COVID-19, leading to shortages, and the World Health Organisation (WHO) wants the company to ensure that supplies don’t just go to wealthy countries. Earlier this week Roche’s Genentech unit said it was facing unprecedented demand for Actemra (tocilizumab) – known as RoActemra …

Amid Actemra shortage, WHO asks Roche to ensure equitable access 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 »

HER2 heats up as Seagen licenses RemeGen ADC for $2.6bn

Seagen is a specialist in antibody-drug conjugates, but has looked to Chinese biotech RemeGen for a HER2-targeting candidate that could challenge rival drugs from AstraZeneca/Daiichi Sankyo and Roche. The US company is paying $200 million upfront for rex-Asian rights to RemeGen’s disitamab vedotin, with another $2.4 billion in possible future payments tied to future successes …

HER2 heats up as Seagen licenses RemeGen ADC for $2.6bn Read More »

Armed with ph3 trial, Roche preps filing for Polivy in first-line DLBCL

Roche has the results it was hoping for in a phase 3 trial of Polivy in newly diagnosed diffuse large B-cell lymphoma (DLBCL) – an indication it thinks could be worth up to $2 billion. The Swiss drugmaker reported top-line results from the POLARIX study this morning, showing that Polivy (polatuzumab vedotin) was able to …

Armed with ph3 trial, Roche preps filing for Polivy in first-line DLBCL 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 »

Roche gets fast FDA review for Tecentriq in adjuvant lung cancer

Roche is preparing for a December verdict form the FDA on adjuvant use of its PD-L1 inhibitor Tecentriq as an adjuvant treatment for some patients with non-small cell lung cancer (NSCLC). The US regulator has just started a priority review of the marketing application for Tecentriq (atezolizumab) – given after surgery and platinum-based chemotherapy – …

Roche gets fast FDA review for Tecentriq in adjuvant lung cancer Read More »

Roche Reports the US FDA’s Acceptance of BLA and Priority Review of Tecentriq (atezolizumab) as an Adjuvant Treatment for NSCLC

Shots: The application is based on the P-III IMpower010 study evaluating the efficacy & safety of Tecentriq vs BSC in 1005 patients in a ratio (1:1) with Stage IB-IIIA NSCLC, following surgical resection and up to 4 cycles of adjuvant cisplatin-based CT The results from an interim analysis showed the reduction in the risk of …

Roche Reports the US FDA’s Acceptance of BLA and Priority Review of Tecentriq (atezolizumab) as an Adjuvant Treatment for NSCLC 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 »

Roche Publishes the Results of Evrysdi (risdiplam) in FIREFISH Study to Treat of Type 1 SMA at NEJM

Shots: The company has reported the results from Part 2 of the FIREFISH study evaluating the efficacy and safety of Evrysdi in 41 infants aged 1-7 mos. with symptomatic Type 1 SMA The study met its 1EP i.e., 29% of infants sitting without support for at least 5 sec., 93% of infants were alive and …

Roche Publishes the Results of Evrysdi (risdiplam) in FIREFISH Study to Treat of Type 1 SMA at NEJM Read More »

FDA starts review of Roche’s eye disease drug, setting up 2022 verdict

The FDA has started a priority review of Roche’s bispecific antibody faricimab for two major causes of blindness, preparing for a market showdown with Bayer and Regeneron’s market-leading Eylea. The US regulator will review the drug for both neovascular or ‘wet’ age-related macular degeneration (AMD) and diabetic macular oedema (DME), as well as diabetic retinopathy …

FDA starts review of Roche’s eye disease drug, setting up 2022 verdict Read More »

Roche Reports the US FDA’s Acceptance of BLA for Faricimab to Treat Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration

Shots: The BLA submission is based on four P-III studies i.e TENAYA, LUCERNE, YOSEMITE & RHINE evaluating the efficacy & safety of faricimab vs aflibercept in patients with nAMD & DME. The LTE studies for faricimab are underway The studies demonstrated non-inferior visual acuity gains and greater reductions in CST, ~50% of patients can extend …

Roche Reports the US FDA’s Acceptance of BLA for Faricimab to Treat Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration Read More »

Angelman syndrome Pipeline: Unmet needs call for a robust pipeline

The necessity of a robust Angelman syndrome pipeline is indispensable at the current moment because of a shortage of any approved therapy option available in the market. The Angelman Syndrome current treatment landscape consists of symptomatic therapy options worth USD 330.2 million in 2017.  Treatment entirely focuses on the management of symptoms and supporting the …

Angelman syndrome Pipeline: Unmet needs call for a robust pipeline Read More »

Roche ‘talking to FDA’ as Alzheimer’s drug moves towards 2022 readout

Phase 3 results with Roche’s amyloid-targeting Alzheimer’s drug gantenerumab may not be due until the second half of last year, but the company is already in discussions with the FDA about a route to approval. There has been speculation since the unexpected approval of Biogen and Eisai’s Aduhelm (aducanumab) last month that other amyloid therapies …

Roche ‘talking to FDA’ as Alzheimer’s drug moves towards 2022 readout Read More »

AstraZeneca bags Imfinzi okay in big Chinese lung cancer market

China has approved AstraZeneca’s PD-1/PD-L1 inhibitor Imfinzi to treat small-cell lung cancer (SCLC), an aggressive form of the disease that accounts for around 15% of all lung cancer cases. The green light from the National Medical Products Administration (NMPA) covers the use of Imfinzi (durvalumab) alongside platinum-based chemotherapy in previously untreated patients with extensive-stage SCLC. …

AstraZeneca bags Imfinzi okay in big Chinese lung cancer market 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 »

Roche Enters into a Clinical Collaboration with Treos Bio for PolyPEPI1018 + atezolizumab in P-I/II Trial to Treat Late Stage Microsatellite Stable Metastatic Colorectal Cancer

Shots: The companies collaborated to evaluate Treos’ PolyPEPI1018 (Polypeptide cancer immunotherapy) + Roche’s atezolizumab (PD-L1-inhibitor) in P-I/II trial in patients with late-stage MSS mCRC which is expected to initiate in Q4’21 Treos has completed a P- I/II OBERTO 101 study for PolyPEPI1018 as 1L maintenance setting in patients with MSS mCRC that demonstrates the therapy …

Roche Enters into a Clinical Collaboration with Treos Bio for PolyPEPI1018 + atezolizumab in P-I/II Trial to Treat Late Stage Microsatellite Stable Metastatic Colorectal Cancer Read More »

Roche Enter into a Collaboration with Mimetas to Develop Human Disease Models for Drug Development

Shots: Mimetas is eligible to receive up front and milestones while Roche will get an option to exclusively license specific disease models and assays for use in drug discovery in IBD and HBV infections Mimetas will be responsible for developing tissue-based disease models and assays in the OrganoPlate that help to increases the predictability of …

Roche Enter into a Collaboration with Mimetas to Develop Human Disease Models for Drug Development Read More »

Roche to Present New data of Hemlibra (emicizumab) in P-IIIb STASEY Study for Hemophilia A at ISTH 2021

Shots: The company will present data from the final analysis of P-IIIb STASEY study of Hemlibra (emicizumab) reinforcing the safety & efficacy of Hemlibra in people with hemophilia A with factor VIII inhibitors Spark will share data from the P-I/II study of SPK-8011, demonstrating that hepatocyte expression of factor VIII can be stable and durable …

Roche to Present New data of Hemlibra (emicizumab) in P-IIIb STASEY Study for Hemophilia A at ISTH 2021 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 »

Atea Pharma Secures $50M Milestone Payment with Roche in the Development of AT-527 for COVID-19

Shots: Atea Pharma achieved a milestone related to the development of AT-527 and is expecting to receive a related payment of $50M under its license agreement with Roche. The company believes that AT-527 is suitable for use in both pre-and post-exposure prophylactic settings and complementary to vaccines The companies are jointly developing AT-527 for the …

Atea Pharma Secures $50M Milestone Payment with Roche in the Development of AT-527 for COVID-19 Read More »

Ambrx tries another IPO as it chases down HER2 rivals

California biotech Ambrx Biopharma is hoping to raise $126 million from a listing on the New York Stock Exchange (NYSE) that will be used in part to fund clinical development of ARX-788, its HER2-targeting antibody drug conjugate (ADC). The Scripps Research spinout could be just 18 months away from licensee NovoCodex reporting results of a …

Ambrx tries another IPO as it chases down HER2 rivals Read More »

PharmaShots Weekly Snapshots (June 07 – 11, 2021)

Vertex and CRISPR Therapeutics Present New Data of CTX001 from 22 Patients with TDT and SCD at EMA 2021 Published: June 11, 2021 | Tags: Vertex, CRISPR Therapeutics, CTX001, TDT, SCD, EMA 2021 AbbVie Reports Results of Four-Year Follow-Up Analysis in P-III CLL14 Trial for Venclyxto/Venclexta to Treat Chronic Lymphocytic Leukemia Published: June 11, 2021 …

PharmaShots Weekly Snapshots (June 07 – 11, 2021) Read More »

Roche Reports New Interim Data of JEWELFISH & RAINBOWFISH Studies for Evrysdi (risdiplam) to Treat Spinal Muscular Atrophy

Shots: The new interim data from two studies i.e JEWELFISH open-label study evaluating Evrysdi in people aged 1 to 60 yrs previously treated with another SMA-targeting therapy & RAINBOWFISH study evaluating Evrysdi in babies from birth to 6 wks. with pre-symptomatic SMA The JEWELFISH showed stabilization in motor function as measured by change from baseline …

Roche Reports New Interim Data of JEWELFISH & RAINBOWFISH Studies for Evrysdi (risdiplam) to Treat Spinal Muscular Atrophy Read More »

Roche’s SARS-CoV-2 Antigen Test Receives CE mark For Self Testing of COVID-19 at Home

Shots: Roche received a CE mark for its SARS-CoV-2 Ag self-test nasal at home setting for COVID 19. The test will be available in countries accepting the CE mark The early version of the test is available in the EU under special approval pathways since Feb, 2021. The test can be performed by individuals using …

Roche’s SARS-CoV-2 Antigen Test Receives CE mark For Self Testing of COVID-19 at Home Read More »

NICE ‘no’ to Roche’s risdiplam for SMA not unexpected, says patient group

NICE has rejected routine NHS funding for Roche’s Evrysdi (risdiplam) for spinal muscular atrophy drug in draft guidance, a decision which doesn’t come as a surprise to patient association SMA UK. The cost-effectiveness agency’s initial assessment is that Evrysdi is simply too expensive at its current price to be provided to the roughly 1,500 people …

NICE ‘no’ to Roche’s risdiplam for SMA not unexpected, says patient group 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 »

Genentech Reports Results of Tecentriq in P-III IMpower010 Study for 1L Treatment of NSCLC

Shots: The P-III IMpower010 involves assessing Tecentriq + BSC in 1,005 participants in a ratio (1:1) with Stage IB-IIIA NSCLC, following surgical resection and up to 4 cycles of adjuvant cisplatin-based CT Results: 34% reduction in risk of death in people with Stage II-IIIA NSCLC. In the larger population of all randomized Stage II-IIIA study …

Genentech Reports Results of Tecentriq in P-III IMpower010 Study for 1L Treatment of NSCLC Read More »

Roche Receives the US FDA’s EUA for cobas SARS-CoV-2 Test to Suspect COVID-19

Shots: Roche’s cobas SARS-CoV-2 test to be use on high-throughput cobas 6800/8800 systems has received the US FDA’s EUA for testing individuals without symptoms or reasons to control the spread of COVID-19 The authorization expands SARS-CoV-2 testing to include people without symptoms and applies to pooled samples containing up to and including 6 individual samples …

Roche Receives the US FDA’s EUA for cobas SARS-CoV-2 Test to Suspect COVID-19 Read More »

Eli Lilly Signs an International Agreements with Four Diabetes Technology Companies for Connected Insulin Pen Solutions

Shots: Eli Lilly collaborates with DexCom, Glooko, myDiabby Healthcare and Roche to integrate the data and technology into connected insulin pen solutions and provide streamlined care for diabetes patients in markets outside the US The 4 companies will provide diabetes management platforms that are well-suited with Lilly’s Tempo Pen and Tempo Smart Button to help …

Eli Lilly Signs an International Agreements with Four Diabetes Technology Companies for Connected Insulin Pen Solutions 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 »

Roche’s Tecentriq gets fourth European lung cancer indication

Roche’s cancer immunotherapy Tecentriq has been granted a new use by European regulators, for the first-line treatment of certain patients with metastatic non-small cell lung cancer (NSCLC). Tecentriq (atezolizumab) has now been used in Europe for adults with metastatic NSCLC whose tumours have high PD-L1 expression. The tumours must also have no epidermal growth factor …

Roche’s Tecentriq gets fourth European lung cancer indication Read More »

Roche’s Tecentriq Receives EC’s Approval as 1L Treatment for Metastatic Non-Small Cell Lung Cancer

Shots: The approval is based on P-III IMpower110 study assessing the efficacy and safety of Tecentriq vs CT in 572 PD-L1-selected, CT-naïve participants in a ratio (1:1) with stage IV non-squamous or squamous NSCLC Results: improvement in OS in people with high PD-L1 expression (20.2 vs 13.1mos.), safety was consistent with its known safety profile …

Roche’s Tecentriq Receives EC’s Approval as 1L Treatment for Metastatic Non-Small Cell Lung Cancer Read More »

ODAC votes to keep bladder cancer labels for Keytruda, Tecentriq

Merck & Co’s Keytruda and Roche’s Tecentriq should stay on the market as first-line treatments for bladder cancer, at least until new clinical data becomes available next year.  That was the conclusion at the second day of a meeting of the FDA’s Oncologic Drugs Advisory Committee (ODAC), convened to discuss three immuno-oncology drugs granted conditional …

ODAC votes to keep bladder cancer labels for Keytruda, Tecentriq Read More »

FDA looks at pulling speedy approvals for three cancer drugs

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

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

CHMP backs Roche’s Enspryng for rare nerve disease NMOSD

Roche’s Enspryng has been recommended for approval in the EU for treating neuromyelitis optica spectrum disorder (NMOSD), extending the treatment options for people with the life-threatening rare disease.  The CHMP has backed the drug in patients aged 12 or more with NMOSD that tests positive for aquaporin-4 (AQP4) antibodies, a biomarker seen in around 80% …

CHMP backs Roche’s Enspryng for rare nerve disease NMOSD 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 »

Roche Receives the US FDA’s Approval for First CDx to Identify Endometrial Cancer Patients Eligible for Immunotherapy

Shots: The US FDA has approved Ventana MMR RxDx panel to identify endometrial cancer patients who are eligible for treatment with GSK’s Jemperli (monothx.) that has received the US FDA’s approval on Apr 22, 2021 The CDx provides clinicians with a standardized testing option that uses a comprehensive panel of DNA mismatch repair (MMR) biomarkers …

Roche Receives the US FDA’s Approval for First CDx to Identify Endometrial Cancer Patients Eligible for Immunotherapy 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 »

Roche axes two pipeline COVID drugs as pandemic hits Q1 pharma sales

Roche has axed two mid-stage COVID drugs from its development pipeline, according to a first quarter results statement showing the pandemic has hit sales in its medicines business. Gone from the pipeline is a phase 2 trial of astegolimab (RG6149), a drug that binds to IL-33 and ST2 in COVID-19 related pneumonia Roche said in …

Roche axes two pipeline COVID drugs as pandemic hits Q1 pharma sales 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 »

Roche’s Evrysdi (risdiplam) Receives Health Canada’s Approval for Spinal Muscular Atrophy in Adults and Children

Shots: The approval is based on two studies i.e. FIREFISH & SUNFISH. The FIREFISH study involves assessing Evrysdi in infants aged 2-7mos. with symptomatic Type 1 SMA, and the SUNFISH study assesses Evrysdi in children & young adults aged 2-25yrs. with Type 2 or 3 SMA Evrysdi demonstrated improvement in motor function, 29.3% of participants …

Roche’s Evrysdi (risdiplam) Receives Health Canada’s Approval for Spinal Muscular Atrophy in Adults and Children Read More »

Evrysdi has ‘real world impact’ on lives of babies with severe SMA, says Roche

Roche’s Genentech unit has released further data from a key trial of Evrysdi, its oral treatment for spinal muscular atrophy (SMA), the rare muscle wasting disease that is often fatal in babies that develop it. There are several treatment options now available for SMA, with Novartis’ ultra-pricey Zolgensma offering a one-off gene therapy, while Biogen’s …

Evrysdi has ‘real world impact’ on lives of babies with severe SMA, says Roche Read More »

Roche and Biocorp Launch Mallya Smart Insulin Pen for Patients with Diabetes in France

Shots: The companies launched the Mallya smart insulin pen device in France to support patients with diabetes. The smart insulin pen is available in pharmacies and is compatible with any disposable insulin pens The device collects and transfers insulin data with 100% accuracy and is rechargeable via its USB port. Mallya automatically collects insulin data …

Roche and Biocorp Launch Mallya Smart Insulin Pen for Patients with Diabetes in France Read More »

Race for hepatitis B drug intensifies as Antios raises $96m for phase 2 trial

Antios has raised $96 million in Series B financing to support the ongoing phase 2 development of its hepatitis B drug candidate, ATI-2173. There are several competitors developing treatments for hepatitis B in what could turn out to be a competitive market. Most people infected with the disease, which can be spread sexually or by …

Race for hepatitis B drug intensifies as Antios raises $96m for phase 2 trial Read More »

Regeneron, Roche injectable antibody drug shows efficacy in preventing Covid-19

A Regeneron Pharmaceuticals antibody cocktail currently authorized for treating Covid-19 now has additional clinical data showing it reduces the risk of infection spread. The drug developer, along with partner Roche, plan to ask regulators to expand the drug’s authorization to include disease prevention.

Roche Report Results of Ab Cocktail (Casirivimab + Imdevimab) in P-III REGN-COV 2069 Trial for Symptomatic COVID 19 Infection

Shots: The P-III REGN-COV 2069 trial involves assessing the efficacy and safety of Ab cocktail (casirivimab (1200 mg, SC) + imdevimab (1200 mg, SC) vs PBO in 1,505 people to prevent symptomatic infection in household contacts of individuals infected with COVID-19 The trial met its 1EP and 2EPs showed an 81% reduction in the risk …

Roche Report Results of Ab Cocktail (Casirivimab + Imdevimab) in P-III REGN-COV 2069 Trial for Symptomatic COVID 19 Infection 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 »

TG Therapeutics completes FDA filing for Roche challenger in CLL

TG Therapeutics has completed its rolling FDA filing for its U2 combination therapy consisting of the antibody ublituximab with the oral drug Ukoniq (umbralisib) as a treatment for chronic lymphocytic leukaemia (CLL). The US pharma is mounting a challenge to Roche, which markets an antibody therapy, Gazyvaro (obinutuzumab) in advanced CLL. Like Gazyvaro, ublituximab targets …

TG Therapeutics completes FDA filing for Roche challenger in CLL Read More »

Roche’s Tecentriq Receives CHMP’s Positive Opinion for 1L Treatment for Metastatic Non-Small Cell Lung Cancer

Shots: The CHMP’s recommendation is based on Phase III IMpower110 study assessing Tecentriq vs CT  in 572 PD-L1-selected, CT-naïve participants in a ratio (1:1) with stage IV non-squamous or squamous NSCLC Results: OS in people with high PD-L1 expression (7.1 vs 3.1mos.); safety profile is consistent with the current profile & no new safety signals …

Roche’s Tecentriq Receives CHMP’s Positive Opinion for 1L Treatment for Metastatic Non-Small Cell Lung Cancer Read More »

PharmaShots Weekly Snapshots (Mar 22 – 26, 2021)

Pfizer and BioNTech Initiate COVID-19 Vaccine Trial in Children Under 12 Published: Mar 26, 2021 | Tags: Pfizer and BioNTech, Initiate, COVID-19 Vaccine Trial, Children, Under 12 Tetra Bio-Pharma Initiates Additional Studies of ARDS-003 in Neuroinflammation and Antiviral Diseases Published: Mar 26, 2021 | Tags: Tetra Bio-Pharma, Initiates, Additional Studies, ARDS-003,  Neuroinflammation, Antiviral Diseases Immunai …

PharmaShots Weekly Snapshots (Mar 22 – 26, 2021) Read More »

Roche Launches New Configurations for Cobas Pro to Increase Testing Efficiency

Shots: Roche launches eight new configurations for Cobas pro integrated solutions in countries accepting the CE mark and is designed to address the individual needs to maximize throughput and efficiency Cobas pro integrated solutions can deliver up to 4,400 tests/ hr., doubling its previous testing capacity. The addition of the new configurations allows labs to …

Roche Launches New Configurations for Cobas Pro to Increase Testing Efficiency Read More »

Roche stops dosing in trial of Huntington’s disease hopeful tominersen

Roche has stopped dosing in a phase 3 trial of tominersen, a potential Huntington’s disease (HD) drug developed with Ionis, after a pre-planned review by independent experts.  The companies had been working on tominersen since December 2017, when Roche licensed it in from Ionis. There were high expectations for tominersen, which the companies hoped would …

Roche stops dosing in trial of Huntington’s disease hopeful tominersen Read More »

Roche Pauses Dosing of Tominersen in P-III GENERATION HD1 for Manifest Huntington’s Disease

Shots: Roche discontinue the dosing in the P-III GENERATION HD1 study that assesses Tominersen (120 mg, every 2mos./120 mg every 4mos., IT) in 791 participants with manifest HD from 18 countries globally The discontinuation is based on the IDMC recommendation on potential benefit/risk profile for study participants that showed no new or emerging safety signals …

Roche Pauses Dosing of Tominersen in P-III GENERATION HD1 for Manifest Huntington’s Disease Read More »

Roche Reports Results of Tecentriq in P-III IMpower010 Study for Patients with Early Lung Cancer

Shots: The P-III IMpower010 study involves assessing Tecentriq vs BSC, in 1,005 participants in a ratio (1:1) with stage IB-IIIA NSCLC, following surgical resection and up to 4 cycles of adjuvant CT The study met its 1EPs showed improvement in DFS in PD-L1+ stage II-IIIA populations and ITT stage IB-IIIA populations NSCLC. The 2EP’s include …

Roche Reports Results of Tecentriq in P-III IMpower010 Study for Patients with Early Lung Cancer 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 »

Roche launches test to monitor emerging coronavirus variants

Roche has launched a new test that will help monitor emerging variants of the SARS-CoV-2 coronavirus. In a statement the company said the cobas SARS-CoV-2 Variant Set 1 Test is designed to detect key spike mutations in virus variants associated with increased human-to-human transmission. Detecting different variants of the virus can help assess the spread …

Roche launches test to monitor emerging coronavirus variants Read More »

Roche launches test to monitor emerging coronavirus variants

Roche has launched a new test that will help monitor emerging variants of the SARS-CoV-2 coronavirus. In a statement the company said the cobas SARS-CoV-2 Variant Set 1 Test is designed to detect key spike mutations in virus variants associated with increased human-to-human transmission. Detecting different variants of the virus can help assess the spread …

Roche launches test to monitor emerging coronavirus variants Read More »

Genentech Reports Two-Year Data of Evrysdi (risdiplam) for People with Type 2 or Type 3 SMA

Shots: Genentech reports the new 2yrs. data from part 2 of SUNFISH study assessing Evrysdi vs PBO in people aged 2-25 years with Type 2 or Type 3 SMA Results: improvement in maintained motor function b/w 12-24mos. as measured by MFM-32; change from baseline in SMAIS score; stabilized motor function after 12mos. as per MFM-32, …

Genentech Reports Two-Year Data of Evrysdi (risdiplam) for People with Type 2 or Type 3 SMA Read More »

Roche Launches Cobas SARS-CoV-2 Variant Test to Detect Emerging Coronavirus Mutations

Shots: The company has launched the cobas SARS-CoV-2 variant set 1 test to detect spike mutations in virus variants including UK (B.1.1.7), South Africa (B.1.351), and Brazil (P.1) The accurate detection and differentiation of SARS-CoV-2 mutations can aid in assessing the spread of circulating variants and monitor their potential impact on diagnostics, vaccines and therapeutics …

Roche Launches Cobas SARS-CoV-2 Variant Test to Detect Emerging Coronavirus Mutations Read More »

Roche’s $1.8B GenMark deal brings a key testing capability for Covid-19 and beyond

Roche already sells a Covid-19 diagnostic. In acquiring GenMark Diagnostics for $1.8B, Roche is adding technology that can detect SARS-CoV-2 along with multiple respiratory diseases in a single test from a single patient sample—a capability the Swiss multinational company does not currently offer.

Roche expands COVID testing portfolio with $1.8bn GenMark deal

Roche has said it will pay $1.8 billion for molecular testing company GenMark, boosting the Swiss company’s diagnostic capabilities and adding rapid COVID tests to its pandemic arsenal.  GenMark’s tests are designed to rapidly detect multiple pathogens from a single patient sample. Of particular interest at the moment are its Respiratory Pathogen Panels, which identify …

Roche expands COVID testing portfolio with $1.8bn GenMark deal Read More »

Roche to Acquire GenMark Diagnostics for $1.8B

Shots: Roche to acquire all outstanding shares of GenMark’s for $24.05/ share in cash, making a total deal value of $1.8B with a premium of ~43% to GenMark’s closing price on Feb 10, 2021. The acquisition is expected to be completed in Q2’21 The acquisition will boost Roche’s molecular diagnostics portfolio and will expand the …

Roche to Acquire GenMark Diagnostics for $1.8B 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 »

Insights+: Breakthrough Therapy Designation by the US FDA in 2020

Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available …

Insights+: Breakthrough Therapy Designation by the US FDA in 2020 Read More »

Roche’s Actemra/RoActemra (tocilizumab) + Veklury Fail to Meet its Primary Endpoints in P-III REMDACTA Study for Patients with Severe COVID-19 Pneumonia

Shots: The P-III REMDACTA study involves assessing Actemra/RoActemra (tocilizumab) + Veklury (remdesivir) vs PBO + Veklury in hospitalized patients with severe COVID-19 pneumonia receiving SOC The study did not meet its 1EPs i.e. improvement in time to hospital discharge up to day28 and failed to meet its 2EPs compared to Veklury alone. The findings will …

Roche’s Actemra/RoActemra (tocilizumab) + Veklury Fail to Meet its Primary Endpoints in P-III REMDACTA Study for Patients with Severe COVID-19 Pneumonia Read More »

Roche’s Tecentriq loses bladder cancer use as FDA crackdown continues

Roche’s Tecentriq is the latest medicine to fall foul of a crackdown by the FDA on drugs that have failed to live up to their early promise. The Swiss pharma said it is voluntarily withdrawing the US indication for the immunotherapy Tecentriq (atezolizumab) in metastatic urothelial carcinoma (mUC) previously treated with chemotherapy. As with AstraZeneca’s …

Roche’s Tecentriq loses bladder cancer use as FDA crackdown continues Read More »

Roche’s Ventana ALK (D5F3) CDx Assay Receives the US FDA’s Approval for the Treatment of ALK-Positive NSCLC

Shots: The US FDA has granted approval of Ventana ALK (D5F3) as a CDx assay to identify ALK+ NSCLC patients eligible for treatment with Pfizer’s drug Lorbrena (lorlatinib) The label expansion approval strengthens Roche’s commitment to personalized healthcare by providing lung cancer patients with access to more treatment options The Ventana ALK (D5F3) CDx assay …

Roche’s Ventana ALK (D5F3) CDx Assay Receives the US FDA’s Approval for the Treatment of ALK-Positive NSCLC Read More »

Double first for Scotland as it backs Roche’s Rozlytrek, Novartis’ Zolgensma

The Scottish Medicines Consortium (SMC) has said Roche’s Rozlytrek can be used by NHS Scotland for the treatment of solid tumours with NTRK gene fusion mutations, regardless of where they occur in the body.  This is the second approval by the SMC for Rozlytrek (entrectinib), coming after the drug was cleared for use in ROS1-positive, …

Double first for Scotland as it backs Roche’s Rozlytrek, Novartis’ Zolgensma Read More »

Roche withdraws Tecentriq for bladder cancer, pullback comes amid FDA review

Blockbuster Roche drug Tecentriq will be pulled from the U.S. market as a bladder cancer treatment—three years after failing clinical tests required to stay on the market. The voluntary withdrawal comes amid an industry-wide FDA review of drugs that were awarded accelerated approval but later failed confirmatory studies.

Roche to Withdraw Tecentriq Indication in Metastatic Bladder Cancer in the US

Shots: The company reported the voluntary withdrawal of the Tecentriq (atezolizumab) indication in the US for prior-platinum treated mUC, bladder cancer The withdrawal was made in consultation with the US FDA to review the accelerated approvals with confirmatory trials that have not met 1EPs and have yet to gain regular approvals. The decision does not …

Roche to Withdraw Tecentriq Indication in Metastatic Bladder Cancer in the US 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 »

Roche Collaborates with Tempest to Evaluate TPST-1120 in a Combination Study as 1L Treatment for Hepatocellular Carcinoma

Shots: The companies collaborated to evaluate TPST-1120 + Tecentriq (atezolizumab) and Avastin (bevacizumab) in P-Ib/II study in ~60 patients with advanced HCC prior not treated with HCC Tempest will retain the global rights to develop & commercialize TPST-1120 while Roche will manage the study operations for a global study TPST-1120 is a first-in-class selective PPAR⍺ …

Roche Collaborates with Tempest to Evaluate TPST-1120 in a Combination Study as 1L Treatment for Hepatocellular Carcinoma Read More »

Regeneron’s Ab Cocktail (casirivimab + imdevimab) Receives the CHMP’s Positive Opinion to Treat COVID-19

Shots: The EMA’s CHMP has recommended the use of casirivimab + imdevimab in patients with confirmed COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19 The CHMP scientific opinion supports national decision making within EU states on the use of the antibodies, prior to the future …

Regeneron’s Ab Cocktail (casirivimab + imdevimab) Receives the CHMP’s Positive Opinion to Treat COVID-19 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 »

Roche on COVID-19 healthcare and testing: the pharmaphorum podcast

For episode 30 I spoke with Dr Ashton Harper, who’s head of medical affairs in the UK and Ireland at Roche Diagnostics, about the pressure COVID-19 has put on healthcare systems. A former NHS doctor, he noted how stressful and draining some days can be when working at healthcare’s frontline – even in normal times, …

Roche on COVID-19 healthcare and testing: the pharmaphorum podcast Read More »

Roche Report Results of Evrysdi (risdiplam) in FIREFISH Study for Infants with Type 1 SMA

Shots: Roche has reported the data from the dose-finding Part 1 of the FIREFISH study assessing Evrysdi in patients aged 1-7mos. with Type 1 SMA. Part 1 evaluated several doses of Evrysdi and determined the therapeutic dose of 0.2 mg/kg for Part 2 Part 1 data demonstrated that 99% of infants survive without permanent ventilation …

Roche Report Results of Evrysdi (risdiplam) in FIREFISH Study for Infants with Type 1 SMA Read More »

Roche Concludes the License Agreement with Chugai for AT-527 to Treat COVID-19 in Japan

Shots: Chugai gets exclusive development and commercializing rights for AT-527 in Japan Earlier, Roche and Atea collaborated to jointly develop AT-527. If approved, Atea to distribute AT-527 in the US and Roche will be responsible for global manufacturing and distribution outside the US AT-527 is an investigational, oral, purine nucleotide prodrug, currently being evaluated in …

Roche Concludes the License Agreement with Chugai for AT-527 to Treat COVID-19 in Japan Read More »

PharmaShots Weekly Snapshots (Feb 15- 19, 2021)

RedHill Signs a Manufacturing Agreement with Cosmo for Movantik and RHB-204  Published: Feb 19, 2021 | Tags: RedHill, Signs, Manufacturing, Agreement, Cosmo, Movantik, RHB-204 Astellas and Seagen Reports Submission of Two BLA to the US FDA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer Published: Feb 19, 2021 | Tags: Astellas, Seagen, Reports, Submission, …

PharmaShots Weekly Snapshots (Feb 15- 19, 2021) Read More »

Roche and PatchAi partner on digital tool for cancer patients

Roche’s Italian subsidiary has joined forces with digital health startup PatchAi to roll out an app that aims to support people diagnosed with cancer. Roche and PatchAi have been working together on the Smart Health Companion (SHC), which was launched to oncology and haematology patients in July 2020, and will now step up their collaboration …

Roche and PatchAi partner on digital tool for cancer patients Read More »

Roche’s Receives the US FDA’s Clearance for Urine Sample Type for BK Virus Quantitative Test

Shots: The US FDA 510K clearance for stabilized urine samples to be used with the cobas BKV test on the cobas 6800/8800 systems. It is also approved for use in CE markets with EDTA plasma and urine stabilized in cobas PCR media as sample types The cobas BKV test provides an alternative to LDTs or …

Roche’s Receives the US FDA’s Clearance for Urine Sample Type for BK Virus Quantitative Test 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 »

Roche Reports Results of Faricimab in Four P-III Studies for Diabetic Macular Edema and Age-Related Macular Degeneration

Shots: The P-III YOSEMITE & RHINE studies involve assessing faricimab (6mg at personalized dosing intervals of up to 4mos. and at fixed 2mos. intervals) vs aflibercept (2mg, fixed 2mos. intervals) in 1891 patients with DME The P-III TENAYA & LUCERNE studies assessing faricimab (6mg administered at fixed intervals of every 2,3 & 4mos. based on …

Roche Reports Results of Faricimab in Four P-III Studies for Diabetic Macular Edema and Age-Related Macular Degeneration Read More »

Roche’s Elecsys GDF-15 Assay Receives the US FDA’s Breakthrough Device Designation as a CDX in Cancer Treatment

Shots: The US FDA grants the BDD for Elecsys GDF-15 assay that is intended for measurement of Growth Differentiation Factor-15 (GDF-15) in cachectic patients aged≥18yrs. with solid tumors for treatment with Pfizer’s PF-06946860 GDF-15 assay helps to identify patients suitable for innovative treatment addressing unintentional weight loss in cancer patients and may provide a precision …

Roche’s Elecsys GDF-15 Assay Receives the US FDA’s Breakthrough Device Designation as a CDX in Cancer Treatment Read More »

PharmaShots Weekly Snapshots (Jan 25- 29, 2021)

Roche Collaborate with Cambridge Quantum Computing to Develop Quantum Algorithm for Drug Discovery and Development Published: Jan 29, 2020 | Tags: Roche, Collaborate, Cambridge Quantum Computing, Develop, Quantum Algorithm, Drug, Discovery, Development Janssen Reports Results of Amivantamab in P-I CHRYSALIS Study for Metastatic or Unresectable NSCLC and EGFR Exon 20 Insertion Mutations Published: Jan 29, 2020 …

PharmaShots Weekly Snapshots (Jan 25- 29, 2021) Read More »

Roche Collaborate with Cambridge Quantum Computing to Develop Quantum Algorithm for Drug Discovery and Development

Shots: CQC collaborates with Roche to design and implement noisy-intermediate-scale-quantum (NISQ) algorithms for early-stage drug discovery and development The collaboration will employ CQC’s quantum chemistry platform ‘EUMEN’, to augment the Roche’s AD research efforts The multi-year collaboration will combine the expertise of both CQC and Roche to advance the application of quantum computing to pharmaceutical …

Roche Collaborate with Cambridge Quantum Computing to Develop Quantum Algorithm for Drug Discovery and Development Read More »

Roche targets wet AMD with faricimab and its 16-week regimen

Twin late-stage trials of Roche’s ophthalmology drug faricimab have hit the mark in “wet” age-related macular degeneration trial, as the company’s challenge to rivals from Novartis and Bayer strengthens. With faricimab Roche is aiming to outperform rivals in a highly competitive market by doubling the time taken between doses compared with standard care to 16 …

Roche targets wet AMD with faricimab and its 16-week regimen Read More »

PharmaShots Weekly Snapshots (Jan 18 – 22, 2021)

Takeda’s Alunbrig (brigatinib) Receives MHLW’s Approval as a 1L and 2L Treatment for ALK+ Advanced or Recurrent NSCLC Published: Jan 22, 2020 | Tags: Takeda, Alunbrig, (brigatinib), Receives, MHLW, Approval,1L and 2L, Treatment, ALK+ Advanced or Recurrent NSCLC MTPA and Aquestive Sign a License and Supply Agreement for Exservan (riluzole) to Treat ALS in the …

PharmaShots Weekly Snapshots (Jan 18 – 22, 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 »

NICE rejects BMS’ Zeposia MS pill in provisional guidance

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

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

Insights+: The US FDA New Drug Approvals in December 2020

The US FDA has approved 7 NDAs and 2 BLA in Nov 2020, 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 105 novel products so far in 2020, including 9 in Dec 2020.   Additionally, last year in 2019, the US FDA has approved …

Insights+: The US FDA New Drug Approvals in December 2020 Read More »

Roche Reports the US FDA’s Acceptance of sNDA and Granted Priority Review for Esbriet (pirfenidone) to Treat UILD

Shots: The sNDA submission is based on a P-II study that involves assessing Esbriet vs PBO in patients aged ≥18-85yrs. with progressive fibrosing UILD for 24wks. The anticipated PDUFA date is May’2021 Results: Over 24wks. predicted median change in FVC measured by home spirometry (-87.7 vs -157.1 mL); change in percent predicted DLco and 6MWD …

Roche Reports the US FDA’s Acceptance of sNDA and Granted Priority Review for Esbriet (pirfenidone) to Treat UILD Read More »

Scotland backs Roche’s Rozlytrek for ROS1 lung cancer

The Scottish Medicines Consortium (SMC) has given a green light to Roche’s Rozlytrek for a rare form of lung cancer, almost seven months after NICE backed the drug in England. Rozlytrek (entrectinib) can now be used by the NHS in Scotland as a treatment option for ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously …

Scotland backs Roche’s Rozlytrek for ROS1 lung cancer Read More »

Angelman Syndrome Market: Insights Into The Recent Late-Stage Drug Failures And Novel Approaches To Treating This Rare Neurogenetic Disorder

Angelman syndrome (AS) is a complex genetic rare disorder that affects the nervous system. The first sign of a child suffering from Angelman syndrome is a delay in development, such as the inability to sit without support or making incoherent babbling sounds. The hallmarks of the syndrome constitute severe physical disabilities, delayed development, intellectual disability, …

Angelman Syndrome Market: Insights Into The Recent Late-Stage Drug Failures And Novel Approaches To Treating This Rare Neurogenetic Disorder 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 »

Roche Reports Updated OS Data of Tecentriq + Avastin in P-III IMbrave150 Study for Unresectable HCC

Shots: The approval is based on P-III IMbrave150 study involves assessing of Tecentriq (1200mg) + Avastin (15 mg/kg) on day 1 of each 21-day cycle vs sorafenib (400mg, bid) on days 1-21 of each 21-day cycle in 501 patients in a ratio (2:1) with unresectable HCC, prior not treated with systemic therapies Results: @median follow-up …

Roche Reports Updated OS Data of Tecentriq + Avastin in P-III IMbrave150 Study for Unresectable HCC Read More »

RNAi biotech Atalanta debuts with $110m plus Biogen and Roche CNS tie-ups

US biotech Atalanta Therapeutics has come out of stealth mode backed with $110m from Biogen and Roche, who have also signed separate partnerships to develop new therapies for neurological diseases using RNA interference (RNAi) technology. While there are RNAi products on the marketplace, with Alnylam becoming the first company to get a product approved in …

RNAi biotech Atalanta debuts with $110m plus Biogen and Roche CNS tie-ups Read More »

Roche’s Xofluza Receives the EC’s Approval for the Treatment of Influenza

Shots: The EC has approved Xofluza (baloxavir marboxil) for uncomplicated influenza in patients aged≥12yrs. Additionally, the EC has approved Xofluza for post-exposure prophylaxis of influenza in individuals aged≥12yrs. The approval follows the CHMP’s positive opinion for Xofluza and is based on P-III CAPSTONE-1, CAPSTONE-2 and BLOCKSTONE studies Xofluza is a first-in-class, single-dose oral therapy, reduces …

Roche’s Xofluza Receives the EC’s Approval for the Treatment of Influenza 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 »

Roche nabs breakthrough tag for TIGIT cancer immunotherapy

Roche’s closely-watched combination of two checkpoint inhibitors – TIGIT-targeting tiragolumab and PD-L1 drug Tecentriq – has claimed breakthrough status from the FDA. Like PD-L1, TIGIT is thought to act as a molecular brake that stops T cells from attacking tumours, and tiragolumab is currently leading the pack among drugs targeting the immune checkpoint. The FDA’s …

Roche nabs breakthrough tag for TIGIT cancer immunotherapy Read More »

Roche set to file ophthalmology drug faricimab in DME

Roche looks set to mount a challenge to Bayer’s ophthalmology drug Eylea in 2021 after its faricimab antibody showed comparable results in diabetic macular oedema (DME) but with half the injections, in twin phase 3 studies. While Eylea (aflibercept) is taken in doses eight weeks apart, results from the YOSEMITE and RHINE studies showed faricimab …

Roche set to file ophthalmology drug faricimab in DME 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 »

PharmaShots Weekly Snapshots (Dec 21-23, 2020)

Roche’s Phesgo (Perjeta + Herceptin) Receives EC’s Approval for the Treatment of HER2-Positive Breast Cancer Published: Dec 23, 2020 | Tags: (Perjeta + Herceptin), EC’s Approval, HER2-positive Breast Cancer, Phesgo, receives, Roche, Treatment AMO Pharma Initiates P-II REACH-CDM study of AMO-02 (tideglusib) to treat Congenital Myotonic Dystrophy Published: Dec 22, 2020 | Tags: AMO Pharma, …

PharmaShots Weekly Snapshots (Dec 21-23, 2020) Read More »

Roche’s Phesgo (Perjeta + Herceptin) Receives EC’s Approval for the Treatment of HER2-Positive Breast Cancer

Shots: The approval is based on P-III FeDeriCa study evaluating the pharmacokinetics, efficacy, and safety of Phesgo + CT vs Perjeta + Herceptin (IV) + CT in 500 patients with HER2-positive early breast cancer treated in the neoadjuvant (before surgery) and adjuvant (after surgery) Result of FeDeriCa Study: The GMR for the 1EPs (1.22) with …

Roche’s Phesgo (Perjeta + Herceptin) Receives EC’s Approval for the Treatment of HER2-Positive Breast Cancer Read More »

Roche claims EU okay for Herceptin/Perjeta combination Phesgo

Roche has secured EU approval for Phesgo, a fixed-dose combination of its breast cancer drugs Herceptin and Perjeta that is easier and cheaper to administer to patients – and also provides a defence against biosimilar competition. Phesgo combines the anti-HER2 antibodies in Herceptin (trastuzumab) and Perjeta (pertuzumab) in a subcutaneous injection that takes a few …

Roche claims EU okay for Herceptin/Perjeta combination Phesgo Read More »

Roche Reports Results of Faricimab in Two Global P-III Studies for Diabetic Macular Edema

Shots: The P-III YOSEMITE & RHINE studies assessing faricimab vs aflibercept in 1891 people living with DME. The studies include 3 treatment arms: faricimab (6mg) administered at personalized dosing intervals of ~16wks and at fixed 8wks. intervals & aflibercept (2mg) at fixed 8wks. intervals The studies met its 1EPs i.e faricimab in both the doses …

Roche Reports Results of Faricimab in Two Global P-III Studies for Diabetic Macular Edema Read More »

PharmaShots Weekly Snapshots (Dec 14-18, 2020)

Sandoz to Launch Hyrimoz (biosimilar, adalimumab) in Canada Published: Dec 17, 2020 | Tags: Authorization, Biosimilar, canada, health, Humira, Hyrimoz, Launch, receives, Sandoz Amgen’s Riabni (biosimilar, rituximab) Receives the US FDA’s Approval for Multiple Diseases Published: Dec 17, 2020 | Tags: Adult, Amgen, approval, Biosimilar, CLL, GPA, MPA, NHL, patients, receives, RIABNI, Rituxan, Rituximab, rituximab-arrx, …

PharmaShots Weekly Snapshots (Dec 14-18, 2020) Read More »

Insights+: The US FDA New Drug Approvals in November 2020

The US FDA has approved 5 NDAs and 1 BLA in Nov 2020, 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 96 novel products so far in 2020, including 6 in Nov 2020. …

Insights+: The US FDA New Drug Approvals in November 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 »

Roche Launches Cobas PIK3CA Mutation Test for Patients with Advanced or Metastatic Breast Cancer

Shots: Roche launches the cobas PIK3CA mutation test for patients with advanced/ m-BC in countries accepting the CE mark The IVT test is a real-time PCR test for the qualitative detection & identification of 17 mutations in exons 2, 5, 8, 10 & 21 in the gene encoding the catalytic subunit of PIK3CA in DNA …

Roche Launches Cobas PIK3CA Mutation Test for Patients with Advanced or Metastatic Breast Cancer Read More »

Digital Diabetes Market to Reach $1.5B by 2024, Research Finds

What You Should Know: – The digital diabetes market is on track to reach $1.5 billion dollars by 2024, according to a new report by Research2Guidance. – The confident growth of digital diabetes care will be driven by the growth of the global addressable market for digital diabetes services. Between 2019 and 2024, the number of diagnosed diabetics …

Digital Diabetes Market to Reach $1.5B by 2024, Research Finds Read More »

PharmaShots Weekly Snapshots (Dec 7-11, 2020)

Roche Launches Elecsys SARS-CoV-2 Antigen Test to Support High-Volume COVID-19 Testing Published: Dec 11, 2020 | Tags: Antigen, COVID-19, High, Laboratory, Launch, patients, Roche, SARS-CoV-2, Support, Suspected, Test, Testing, Volume Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan Published: Dec 10, 2020 | Tags: Casirivimab, Chugai, Commercialization, COVID-19, Development, Imdevimab, In-License Agreement, Japan, Roche, …

PharmaShots Weekly Snapshots (Dec 7-11, 2020) Read More »

Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan

Shots: Chugai get an exclusive development and commercialization agreement in Japan for Roche’s Ab cocktail of casirivimab and imdevimab to combat COVID-19 Earlier, Roche & Regeneron collaborated for the development & commercialization of Ab cocktail where Regeneron will distribute the treatment in the US while Roche will be lead manufacturing and distribution activities outside the …

Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan Read More »

Roche Launches Elecsys SARS-CoV-2 Antigen Test to Support High-Volume COVID-19 Testing

Shots: Roche has launched Elecsys SARS-CoV-2 Ag test as an aid in the diagnosis of SARS-CoV-2 infections, in the markets accepting the CE Mark. Additionally, Roche has also filed a EUA to the US FDA The test showed 94.5% sensitivity across 200 PCR confirmed symptomatic individuals & 99.9% specificity across 2747 PCR negative symptomatic & …

Roche Launches Elecsys SARS-CoV-2 Antigen Test to Support High-Volume COVID-19 Testing Read More »

Roche Presents Results of Tecentriq (atezolizumab) in P-III IMvigor010 Study for MIUC at ESMO 2020

Shots: Roche reports an exploratory analysis of P-III IMvigor010 study assessing efficacy and safety of adjuvant treatment with Tecentriq vs observation in 809 people with MIUC, who are at high risk of recurrence following resection Results: in people with ctDNA, DFS Median (5.9 vs 4.4 mos.); median OS (25.8 vs 15.8 mos.). As presented in …

Roche Presents Results of Tecentriq (atezolizumab) in P-III IMvigor010 Study for MIUC at ESMO 2020 Read More »

Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials

Shots: Roche allied with Moderna to utilize the Elecsys anti-SARS-CoV-2 S Ab test in mRNA-1273 study. The collaboration will facilitate the quantitative measurement of SARS-CoV-2 Abs and help to establish a correlation b/w vaccine-induced protection and levels of anti-RBD Abs The alliance follows US FDA’s EUA for the Elecsys anti-SARS-CoV-2 S Ab test. Moderna’s vaccine …

Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials Read More »

Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials

Shots: Roche allied with Moderna to utilize the Elecsys anti-SARS-CoV-2 S Ab test in mRNA-1273 study. The collaboration will facilitate the quantitative measurement of SARS-CoV-2 Abs and help to establish a correlation b/w vaccine-induced protection and levels of anti-RBD Abs The alliance follows US FDA’s EUA for the Elecsys anti-SARS-CoV-2 S Ab test. Moderna’s vaccine …

Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials Read More »

Roche Highlights its Bispecific Antibody Portfolio Across a Range of Blood Cancers at ASH 2020

Shots: The company presented the new data of its T-cell engaging bispecific Abs, mosunetuzumab, glofitamab and cevostamab at ASH 2020, demonstrating encouraging activity across multiple types of blood cancer Roche divulges that its mosunetuzumab & glofitamab showed promising responses across multiple types of NHL, including R/R FL & DLBCL, reinforcing from the P-I/Ib GO29781 study …

Roche Highlights its Bispecific Antibody Portfolio Across a Range of Blood Cancers at ASH 2020 Read More »

Roche Reports of Polivy + Bendamustine and MabThera / Rituxan in P-lb/ll GO29365 Study for R/R Diffuse Large B-Cell Lymphoma

Shots: The P-lb/ll GO29365 study involves assessing of Polivy (polatuzumab vedotin) + BR vs BR as monthx. in 106 patients with r/r DLBCL who are not eligible for stem cell transplant Result: @48.9mos. CR rate (42.5% vs 17.5%); m-PFS (9.2 vs 3.7 mos.); m-OS (12.4 vs 4.7 mos.); New data from the extension cohort, in …

Roche Reports of Polivy + Bendamustine and MabThera / Rituxan in P-lb/ll GO29365 Study for R/R Diffuse Large B-Cell Lymphoma Read More »

Roche Presents Results of Hemlibra Reinforcing the Long-Term Benefits for Hemophilia A at ASH 2020

Shots: The 4 pivotal HAVEN studies (HAVEN-1, 2, 3, 4) included pooled data from 401 people with hemophilia A with/ out factor VIII inhibitors, with a median duration efficacy period of 120.4wks. Hemlibra maintained low treated bleed rates with ABR remaining low throughout the evaluation period at 1.4. The proportion of participants who experienced 0 …

Roche Presents Results of Hemlibra Reinforcing the Long-Term Benefits for Hemophilia A at ASH 2020 Read More »

Roche Reports Long-Term Benefits of Venclexta/Venclyxto Based Combination for R/R Chronic Lymphocytic Leukemia

Shots: Five-year data from P-III MURANO trial shows sustained PFS with Venclexta/Venclyxto + MabThera/Rituxan vs BR in patients with r/r CLL The data showed a reduction in the risk of disease progression or death by 81%, m-OS (82.1% vs 62.2%), patients who completed 2yrs. of treatment without the progressive disease, 63.8% had uMRD The P-III …

Roche Reports Long-Term Benefits of Venclexta/Venclyxto Based Combination for R/R Chronic Lymphocytic Leukemia 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 »

TG Therapeutics challenges Roche with FDA filing for CLL drug

US biotech TG Therapeutics has begun a rolling filing with the FDA for its combination therapy for chronic lymphocytic leukaemia, in a challenge to Roche. The New York-based firm has requested approval for the combination of its anti-CD20 antibody ublituximab and umralisib, an oral drug that inhibits PI3K-delta and CK-1 epsilon. The FDA had already …

TG Therapeutics challenges Roche with FDA filing for CLL drug Read More »

Roche, Blueprint raise pressure on Lilly with new Gavreto approval

The FDA has cleared Roche and Blueprint Medicine’s Gavreto for a new use in RET-mutated thyroid cancer, putting it on a level playing field with Eli Lilly’s rival therapy Retevmo. The US regulator says Gavreto (pralsetinib) can be used to treat patient aged over 12 with advanced or metastatic RET-mutant thyroid tumours, adding to its …

Roche, Blueprint raise pressure on Lilly with new Gavreto approval Read More »

Swiss start-up Noema raises $59m to develop neurology drugs offloaded by Roche

Swiss biotech Noema has raised 54 million Swiss francs ($59m) to develop four neurological disorder drugs licensed in from Roche. The company is developing four phase 2 drugs brought in from Roche after the big Swiss pharma decided somebody else should take the risk of developing them. Roche, which decided the products were surplus to …

Swiss start-up Noema raises $59m to develop neurology drugs offloaded by Roche Read More »

PharmaShots Weekly Snapshot (Nov 23 – 27, 2020)

Merck Collaborates with Siemens for the Digitalization of Production Published: Nov 26, 2020 | Tags: Agreement, Collaborative, Digitalization, Merck, Siemens, Sign CoSara Receives CDSCO’s Approval for its Saragene COVID-19 2-Gene Multiplex Test Published: Nov 26, 2020 | Tags: approval, CDSCO, Co-Diagnostics JV CoSara, COVID-19 2-gene multiplex RT-PCR, India, Manufacture, receives, Saragene, Sell, Test PostEra Collaborates …

PharmaShots Weekly Snapshot (Nov 23 – 27, 2020) Read More »

FDA approves Roche’s Xofluza to prevent flu spreading in families

The FDA has approved a new use for Xofluza (baloxavir marboxil) from Roche’s Genentech unit, to prevent people developing flu after coming into contact with an infectious person. Xofluza has already been on the market for two years, and already had licensed uses to treat uncomplicated flu and those at high risk of complications. With …

FDA approves Roche’s Xofluza to prevent flu spreading in families Read More »

Roche’s Xofluza (baloxavir marboxil) Receives the US FDA’s Approval for Post-Exposure Prevention of Influenza

Shots: The approval is based on P-III BLOCKSTONE study assessing a single dose of Xofluza vs PBO in household members who were living with someone with influenza confirmed by a rapid influenza diagnostic test Results: The proportion of household members aged ≥12yrs. who developed influenza (1% vs 13%), well-tolerated with no new safety signals Xofluza …

Roche’s Xofluza (baloxavir marboxil) Receives the US FDA’s Approval for Post-Exposure Prevention of Influenza 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 »

Lead Pharma signs $308m deal to develop small molecule drugs with Roche

Lead Pharma has signed a potential 260 million euro ($308 million) deal with Roche to develop small molecule drugs for immune diseases. The deal will revolve around a single undisclosed drug target and will see the Dutch biotech receive 10 million euros up front from Roche. Lead will lead the selection of a pre-clinical drug …

Lead Pharma signs $308m deal to develop small molecule drugs with Roche Read More »

Roche Signs a License Agreement with Lead Pharma to Develop Oral Therapies for Immune-Mediated Diseases

Shots: Lead Pharma receives ~$11.86M upfront and is eligible to receive funding and ~$307.9 as research, development, regulatory and commercial milestones along with royalties on sales of small molecules The companies will collaborate in research activities up to the selection of a pre-clinical candidate after which Roche will be responsible for the development and global …

Roche Signs a License Agreement with Lead Pharma to Develop Oral Therapies for Immune-Mediated Diseases Read More »

Roche’s Xofluza (baloxavir marboxil) Receives CHMP’s Recommendation for Approval to Treat Influenza

Shots: The EMA’s CHMP has recommended the approval of Xofluza (baloxavir marboxil) for the treatment of uncomplicated influenza in patients aged ≥12yrs. Xofluza has also been recommended for approval as a preventive treatment (post-exposure prophylaxis) of influenza in individuals aged ≥12yrs. The CHMP recommendation is based on the results of the P-III CAPSTONE-1, CAPSTONE-2 and …

Roche’s Xofluza (baloxavir marboxil) Receives CHMP’s Recommendation for Approval to Treat Influenza Read More »

Roche’s Herceptin/Perjeta combo product nears EU approval

The EMA’s human medicines committee has recommended approval of a fixed-dose combination of Roche’s breast cancer drugs Herceptin and Perjeta – part of the company’s defense against Herceptin biosimilars. Called Phesgo, the new product contains the active substances in Herceptin (trastuzumab) – already facing lower-cost competition in the US and Europe – and Perjeta (pertuzumab), …

Roche’s Herceptin/Perjeta combo product nears EU approval 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 …

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

NICE backs chemo-free CLL combination from AbbVie and Roche

Previously treated patients with chronic lymphocytic leukaemia (CLL) in England will get a chemotherapy-free treatment option after NICE recommended NHS funding for a combination of AbbVie’s Venclyxto and Roche’s Gazyva. The decision by NICE allows for the 12-month fixed duration treatment option based on data from the phase 3 CLL14 trial. This showed the combination …

NICE backs chemo-free CLL combination from AbbVie and Roche Read More »

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, …

PharmaShots Weekly Snapshot (Nov 02-06, 2020) Read More »

Europe approves Roche’s Tecentriq liver cancer combination

The European Commission has approved Roche’s Tecentriq immunotherapy, in combination with its established cancer drug Avastin, for patients with the most common form of liver cancer. Tecentriq (atezolizumab) can be used with Avastin (bevacizumab) for adults with advanced or unresectable hepatocellular carcinoma (HCC) who have not received systemic therapy. Approval is based on findings of …

Europe approves Roche’s Tecentriq liver cancer combination Read More »

Roche’s Tecentriq in Combination with Avastin Receives China NMPA’s Approval for the Treatment of Unresectable Hepatocellular Carcinoma

Shots: The approval was based on the P-III IMbrave150 study (n=501) assessing the combination of Tecentriq (1200 mg, IV) and Avastin (15 mg/kg, IV) or sorafenib (400 mg, bid) in unresectable HCC patients who had not received prior systemic therapy which included analyses of a cohort of Chinese patients (n=194) from the same study Results: …

Roche’s Tecentriq in Combination with Avastin Receives China NMPA’s Approval for the Treatment of Unresectable Hepatocellular Carcinoma 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 …

PharmaShots’ Key Highlights of Third Quarter 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 …

PharmaShots Weekly Snapshot (Oct 19 – 23, 2020) Read More »

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 …

Top 20 Immunology Companies Based 2019 Immunology Segment Revenue Read More »

Roche Collaborates with Atea Pharmaceuticals to Develop AT-527 for COVID-19

Shots: The companies will collaborate to develop, manufacture, and distribute AT-527 to combat COVID-19. If approved, Atea will be responsible for distributing the treatment option in the US, with the option to request Genentech’s support, and Roche will be responsible for distribution outside the US The therapy is currently being evaluated in P-II study for …

Roche Collaborates with Atea Pharmaceuticals to Develop AT-527 for COVID-19 Read More »

Roche to co-develop remdesivir rival in partnership with Atea

Roche may not be the first company that comes to mind for a COVID-19 treatment, but the Swiss firm is taking a big swing at the market to rival Gilead’s remdesivir.  The company has joined forces with Atea Pharmaceuticals to develop, manufacture and distribute Atea’s investigational oral direct-acting antiviral AT-527. AT-527 works by blocking the …

Roche to co-develop remdesivir rival in partnership with Atea Read More »

Babyscripts Forms Commercial Partnership with Roche to Develop RPM Programs for Pregnancy

What You Should Know:   – Babyscripts today announced a commercial partnership with Roche Diagnostics, a division of the world’s largest biotech company and a global pioneer in pharmaceuticals and diagnostics.  – Roche will partner with Babyscripts on the development of Babyscripts’ remote patient monitoring (RPM) programs to leverage groundbreaking data science through the next generation of RPM in …

Babyscripts Forms Commercial Partnership with Roche to Develop RPM Programs for Pregnancy Read More »

Roche and Prothena to Advance Prasinezumab in P-IIb Study for Patients with Early Parkinson’s Disease

Shots: The companies will advance the prasinezumab into a P-IIb study in patients with early Parkinson’s disease based on positive signals of efficacy consistent with disease modification in the PASADENA study The study is designed to further assess the efficacy of prasinezumab by expanding upon the patient population enrolled in PASADENA study to include patients …

Roche and Prothena to Advance Prasinezumab in P-IIb Study for Patients with Early Parkinson’s Disease Read More »

Roche Collaborates with Genesis Therapeutics for AI-Driven Drug Discovery

Shots: Genesis to receive an up front and is eligible to receive pre/ clinical and regulatory milestones along with royalties on sales of approved drugs emerges from the collaboration The collaboration leverages Genesis’ graph machine learning and drug discovery expertise to identify drug candidates for therapeutic targets across multiple disease areas Genesis has developed Dynamic …

Roche Collaborates with Genesis Therapeutics for AI-Driven Drug Discovery Read More »

FDA grants full approval for Roche/AbbVie’s Venclexta in AML combination therapies

Combination therapies involving Roche and AbbVie’s cancer drug Venclexta have been formally approved by the FDA in acute myeloid leukaemia, following supportive data from late-stage studies. The combination therapies had previously been marketed following accelerated approval in November 2018 on the basis of early stage results. But accelerated approval is only a temporary measure and …

FDA grants full approval for Roche/AbbVie’s Venclexta in AML combination therapies 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, …

PharmaShots Weekly Snapshot (Oct 12-16, 2020) Read More »

COVID-19 tests prop up Roche as US biosimilars bite in Q3

Roche’s pharmaceutical revenues have been hit by falling sales in its pharma division in Q3 but a spike in demand for COVID-19 tests spared the Swiss company’s blushes. Sales of its “big three” cancer drugs were all down considerably in Q3 as cheaper biosimilars gained market share in the US. Avastin was down 30% compared …

COVID-19 tests prop up Roche as US biosimilars bite in Q3 Read More »

Roche Signs a License Agreement with Dyno to Develop AVV Gene Therapy for ~$1.8B

Shots: Dyno to receive upfront and is eligible to receive ~$1.8B milestones including development and commercial milestones along with royalties on any product emerges during the collaboration Dyno will be responsible for the design of novel AAV capsids with improved functional properties for gene therapy while Roche and Spark will conduct preclinical, clinical, and commercialization …

Roche Signs a License Agreement with Dyno to Develop AVV Gene Therapy for ~$1.8B Read More »

Roche working “around the clock” to tackle UK test supply problems

Supplies of swabs for coronavirus and other critical NHS tests for diseases like cancer, diabetes and heart disease have been threatened by a failure at a facility operated by Roche. The company said the problems – which also include other items like reagents and screening kits – have resulted from a switch to a new …

Roche working “around the clock” to tackle UK test supply problems Read More »

Roche working “around the clock” to tackle UK test supply problems

Supplies of swabs for coronavirus and other critical NHS tests for diseases like cancer, diabetes and heart disease have been threatened by a failure at a facility operated by Roche. The company said the problems – which also include other items like reagents and screening kits – have resulted from a switch to a new …

Roche working “around the clock” to tackle UK test supply problems Read More »

Roche pays $200m for Vaccibody’s cancer vaccine drug

Roche’s Genentech unit has paid $200 million to develop an individualised cancer vaccine with Norwegian biotech Vaccibody, which focuses on targets known as neoantigens that spring up as tumours grow and mutate. The deal with the Oslo-based company is worth up to $715 million, with potential milestone payments worth up to $515 million on top …

Roche pays $200m for Vaccibody’s cancer vaccine drug 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, …

PharmaShots Weekly Snapshot (Aug 17 -21 2020) Read More »

Coronavirus pharma news round-up 21/08/20

New insights into smell and taste loss symptoms, artificial intelligence and further encouraging data from a vaccine candidate hit the headlines this week as the COVID-19 coronavirus pandemic continues. Here we highlight the biggest R&D, market access and digital coronavirus news of the past week. Pfizer and BioNTech have said their COVID-19 vaccine could be …

Coronavirus pharma news round-up 21/08/20 Read More »

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 …

Mission successful for Novartis after FDA approves ofatumumab in MS Read More »

NICE recommends regular NHS funding for Roche’s lymphoma drug Polivy

NICE has recommended regular NHS funding for Roche’s Polivy in certain lymphoma patients in final draft guidance, overturning a previous rejection. The new guidance recommends Polivy (polatuzumab vedotin) in combination with rituximab and bendamustine, for adults with diffuse large B-cell lymphoma (DLBCL), in second line when patients cannot have a stem cell transplant. Around 4,800 …

NICE recommends regular NHS funding for Roche’s lymphoma drug Polivy Read More »

Regeneron recruits Roche to make COVID-19 antibody drug REGN-COV2

Roche has agreed to help Regeneron manufacture its COVID-19 antibody cocktail REGN-COV2, which started late-stage clinical testing a few weeks ago, in a deal that could more than triple supplies of the drug if it gets approved. Regeneron is already working on ramping up manufacturing capacity for REGN-COV2, with the help of $450 million in …

Regeneron recruits Roche to make COVID-19 antibody drug REGN-COV2 Read More »

Roche’s Tecentriq + Bevacizumab Receive Health Canada’s Approval as 1L Treatment for Unresectable or Metastatic Hepatocellular Carcinoma

Shots: The approval is based on P-III IMbrave150 study assessing Tecentriq (1200 mg) + bevacizumab (15 mg/kg, q3w, IV) vs sorafenib (400mg, bid) in 501 patients in a ratio (2:1) with unresectable or metastatic HCC, prior not treated with systemic therapies Results: 42% reduction in risk of death (OS); 41% reduction the risk of disease …

Roche’s Tecentriq + Bevacizumab Receive Health Canada’s Approval as 1L Treatment for Unresectable or Metastatic Hepatocellular Carcinoma Read More »

Regeneron Collaborates with Roche to Improve the Global Supply of REGN-COV2 Against COVID-19

Shots: The two global companies collaborated to develop, manufacture, and distribute REGN-COV2 across the globe. The agreement is expected to increase the supply of REGN-COV2 to at least 3.5 times the current capacity with the potential for expanding it further Regeneron will lead the distribution in the US while Roche will be responsible for the …

Regeneron Collaborates with Roche to Improve the Global Supply of REGN-COV2 Against COVID-19 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 »

Roche’s Enspryng (satralizumab-mwge) Receives the US FDA’s Approval for Neuromyelitis Optica Spectrum Disorder

Shots: The approval is supported by P-III SAkuraStar and SAkuraSky studies involve assessing Enspryng (120mg, SC, q4w) as a monothx. & as an add-on therapy to baseline IST vs PBO in 95 & 83 patients aged 20-70 &  13-73yrs. in a ratio (2:1) & (1:1) administered at week 0,2 & 4 in patients with NMOSD …

Roche’s Enspryng (satralizumab-mwge) Receives the US FDA’s Approval for Neuromyelitis Optica Spectrum Disorder Read More »

Roche takes on Alexion as FDA approves satralizumab in NMOSD

The FDA has approved Roche’s satralizumab for the rare autoimmune disorder Neuromyelitis Optica Spectrum Disorder (NMOSD), under the brand name Enspryng. Roche is taking on Alexion’s blockbuster Soliris (eculizumab), which was approved in NMOSD last year and in June Viela Bio, a spinoff from AstraZeneca, also won approval for another rival, Uplinza (inebilizumab). The big …

Roche takes on Alexion as FDA approves satralizumab in NMOSD 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, …

PharmaShots Weekly Snapshot (Aug 10 – 14, 2020) Read More »

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

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

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

Roche Reports the US FDA’s Acceptance of sBLA for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications

Shots: The US FDA has accepted the sBLA for a new self-administration option for Xolair across all approved indications in the US. The company anticipates the approval of the therapy in Q1’21 The acceptance is based on the efficacy and safety profile of Xolair in allergic asthma and chronic idiopathic urticaria (CIA) If approved, Xolair’s …

Roche Reports the US FDA’s Acceptance of sBLA for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications Read More »

Roche Collaborates with Celleron Therapeutics for Emactuzumab to Treat Patients with Tenosynovial Giant Cell Tumor

Shots: Celleron will receive an exclusive global right for the clinical development, manufacturing, and commercialization of emactuzumab (formerly RG7155 and RO5509554). The companies expect the closing of an agreement by the end of 2020 86% of TGCT patients treated with emactuzumab responded to the drug, with 68% of people experiencing a PR within 6 weeks …

Roche Collaborates with Celleron Therapeutics for Emactuzumab to Treat Patients with Tenosynovial Giant Cell Tumor Read More »

Celleron targets Daiichi Sankyo with Roche’s unwanted rare cancer drug

UK biotech Celleron Therapeutics has bought a licence to develop, manufacture and market emactuzumab, an unwanted drug from Roche’s pipeline that could be used in a rare tendon sheath cancer already targeted by Daiichi Sankyo. Emactuzumab is a monoclonal antibody designed to target and deplete macrophages, a kind of white blood cell, in tumour tissue. …

Celleron targets Daiichi Sankyo with Roche’s unwanted rare cancer drug Read More »

FDA’s Ok to Roche’s Oral SMA Therapy; Roche’s Etrolizumab Mixed Results in Ulcerative Colitis; Secura receives rights to Copiktra from Verastem

Roche Set to Compete With Biogen and Novartis in the SMA Market With its First Oral Therapy  The US FDA has recommended the use of Evrysdi (risdiplam), a candidate of Genentech, a Roche company, for spinal muscular atrophy (SMA), an inherited neuromuscular disease resulting in muscle atrophy, in adults and children two months of age …

FDA’s Ok to Roche’s Oral SMA Therapy; Roche’s Etrolizumab Mixed Results in Ulcerative Colitis; Secura receives rights to Copiktra from Verastem Read More »

Roche’s ulcerative colitis drug etrolizumab looks shaky after data roll-out

Roche’s late-stage trial programme for ulcerative colitis candidate etrolizumab has generated some positive and negative results, but leans firmly towards the latter. The Swiss drugmaker has acknowledged that the dual-acting anti-integrin antibody – which is trying to chase down Takeda’s blockbuster Entyvio in UC – generated “disappointing” results from the programme, which is billed as …

Roche’s ulcerative colitis drug etrolizumab looks shaky after data roll-out Read More »

Roche Report Mixed Results of Etrolizumab in P-III Studies for Patients with Moderately to Severely Active Ulcerative Colitis

Shots: In the HIBISCUS I induction study, in patients without prior anti-TNF treatment, etrolizumab met its 1EPs while in HIBISCUS II study in the same kind of people, it did not meet its 1EPs. In the HICKORY study, in patients with prior anti-TNF treatment, therapy met its 1EPs at induction but not at maintenance In …

Roche Report Mixed Results of Etrolizumab in P-III Studies for Patients with Moderately to Severely Active Ulcerative Colitis Read More »

Roche takes on pricey rivals as FDA approves SMA drug

Roche is hoping to undercut hugely expensive rivals after the FDA approved its oral spinal muscular atrophy (SMA) drug Evrysdi (risdiplam). Evrysdi is the third treatment approved for SMA, an ultra-rare muscle wasting disease that can begin in early childhood, after Biogen’s Spinraza (nusinersen) and Novartis’ Zolgensma (onasemnogene abeparvovec). But Spinraza costs $750,000 in the …

Roche takes on pricey rivals as FDA approves SMA drug Read More »

Roche’s Evrysdi (risdiplam) Receives the US FDA’s Approval for SMA in Adults and Children

Shots: The US FDA has approved Evrysdi to treat SMA in adults and children ≥ 2mos. The approval is based on two clinical studies designed to represent a broad spectrum of people living with SMA: FIREFISH in symptomatic infants aged 2-7 mos, and SUNFISH in children and adults aged 2-25yrs. The two studies demonstrated improvements …

Roche’s Evrysdi (risdiplam) Receives the US FDA’s Approval for SMA in Adults and Children Read More »

Roche’s Tecentriq flunks triple-negative breast cancer trial

Roche’s hopes of extending the use of its PD-L1 inhibitor Tecentriq in triple-negative breast cancer (TNBC) have been dashed by a late-stage trial failure looking at the drug in combination with chemotherapy. Adding Tecentriq to treatment with paclitaxel as a first-line treatment for TNBC patients whose tumours expressed the biomarker PD-L1 did not lengthen the …

Roche’s Tecentriq flunks triple-negative breast cancer trial Read More »

Roche’s Tecentriq (atezolizumab) + Paclitaxel Fail to Meet the Primary Endpoint in P-III IMpassion131 Study for Patients with Metastatic Triple-Negative Breast Cancer

Shots: The P-III IMpassion131 study involves assessing of Tecentriq + paclitaxel vs PBO + paclitaxel, in 651 people in a ratio (2:1) with previously untreated, inoperable, LA/ m-TNBC The study did not meet its 1EPs of PFS for 1L treatment of people with m-TNBC) in the PD-L1+ population.  The data for 2EPs of OS showed …

Roche’s Tecentriq (atezolizumab) + Paclitaxel Fail to Meet the Primary Endpoint in P-III IMpassion131 Study for Patients with Metastatic Triple-Negative Breast Cancer Read More »

Roche’s cobas Epstein-Barr Virus Test Receives the US FDA’s Authorization for Transplant Patients

Shots: The US FDA has granted de novo class II for cobas EBV test, providing HCPs a tool for monitoring transplant patients at risk for complications from infections or reactivations of EBV The cobas EBV test is a PCR viral load test that runs on the fully automated and widely available cobas 6800/8800 systems and …

Roche’s cobas Epstein-Barr Virus Test Receives the US FDA’s Authorization for Transplant Patients Read More »

Redx shares soar after IPF drug licence deal with AstraZeneca

Shares in Redx Pharma were soaring this morning after it licensed its preclinical fibrotic disease drug RXC006 to AstraZeneca. The company’s shares were valued as high as 95p on the London Stock Exchange following the announcement, the highest they had been since 2015. AstraZeneca has bought an exclusive global licence to develop and market RXC006, …

Redx shares soar after IPF drug licence deal with AstraZeneca Read More »

Roche’s NTRK tumour-agnostic therapy Rozlytrek approved in Europe

Roche’s tumour-agnostic therapy Rozlytrek has been approved in the European Union for people with tumours with the NTRK mutation, meaning Bayer’s class rival faces competition in Europe for the first time. Last September Bayer’s Vitrakvi became the first NTRK inhibitor class drug approved in Europe and the first ever drug licensed to tackle tumours solely …

Roche’s NTRK tumour-agnostic therapy Rozlytrek approved in Europe Read More »

Roche’s Rozlytrek Receives EC’s Conditional Marketing Authorization for NTRK Fusion-Positive Solid Tumors and ROS1-Positive Advanced NSCLC

Shots: The approval is based on integrated analysis including data from 74 people with LA/ m-NTRK fusion-positive solid tumors (14 tumor types) & 161 people with ROS1+ NSCLC of the pivotal P-II STARTRK-2, P-I STARTRK-1 and P-I ALKA-372-001 trials, and data from the P-I/II STARTRK-NG study in pediatric patients Result: in NTRK fusion+ solid tumors, …

Roche’s Rozlytrek Receives EC’s Conditional Marketing Authorization for NTRK Fusion-Positive Solid Tumors and ROS1-Positive Advanced NSCLC 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 …

PharmaShots Weekly Snapshot (Jul 27- 31, 2020) Read More »

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 »

Roche Receives the US FDA’s Approval for VENTANA HER2 Dual ISH Test as CDx to Identify Breast Cancer

Shots: The US FDA has approved the new VENTANA HER2 Dual ISH DNA Probe Cocktail assay to detect HER2 biomarker in BC and as a CDx for Herceptin (trastuzumab) therapy. The assay was launched as a CE IVD in Apr’2019 The assay is designed to be completed within the same day, enabling clinicians to get …

Roche Receives the US FDA’s Approval for VENTANA HER2 Dual ISH Test as CDx to Identify Breast Cancer Read More »

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

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

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

Roche’s Tecentriq + Cotellic and Zelboraf Receives the US FDA’s Approval for Patients with Advanced Melanoma

Shots: The approval is based on P-III IMspire150 study assessing Tecentriq (atezolizumab) + Cotellic  (cobimetinib) + Zelboraf (vemurafenib) vs  PBO + Cotellic +   Zelboraf in patients with BRAF V600 mutation-positive advanced melanoma Results: mPFS (15.1 vs 10.6mos.); the safety profile of the Tecentriq combination was consistent with the known safety profiles of the individual medicines. …

Roche’s Tecentriq + Cotellic and Zelboraf Receives the US FDA’s Approval for Patients with Advanced Melanoma Read More »

Roche doubles down on tau for Alzheimer’s, licensing UCB drug for $120m

Roche already has one Alzheimer’s candidate in its pipeline targeting tau, but has added a second via a deal with Belgian drugmaker UCB worth up to $2 billion. The Swiss pharma group is paying $120 million upfront for exclusive global rights to UCB0107, an anti-tau antibody that is in a phase 1 trial in another …

Roche doubles down on tau for Alzheimer’s, licensing UCB drug for $120m Read More »

Roche’s Actemra/RoActemra (tocilizumab) Fails to Meet the Primary Endpoint in P-III COVACTA Study for Patients with COVID-19 Associated Pneumonia

Shots: The P-III COVACTA study involves assessing of Actemra/RoActemra (IV) + SOC vs PBO + SOC in adult patients hospitalized with severe COVID-19 associated pneumonia. Patients will be followed for 60 days post-randomization The study did not meet its 1EPs i.e. improvement in clinical status and 2EPs i.e. difference in patient mortality @4wks. (19.7% vs …

Roche’s Actemra/RoActemra (tocilizumab) Fails to Meet the Primary Endpoint in P-III COVACTA Study for Patients with COVID-19 Associated Pneumonia Read More »

Setback in COVID-19 effort as Roche’s Actemra fails in key trial

Roche’s anti-inflammatory drug Actemra has failed in a phase 3 clinical trial that was testing to see if it improved the condition of patients with COVID-19 associated pneumonia. The COVACTA trial of Actemra (tocilizumab) did not meet its primary endpoint of improved clinical status, or the secondary endpoint of reduced patient mortality. The rationale behind …

Setback in COVID-19 effort as Roche’s Actemra fails in key trial Read More »

Roche and UCB Collaborate to Develop UCB0107 for Alzheimer’s Disease

Shots: UCB to receive $120M and is eligible to receive $2B as cost reimbursement, development, and commercial milestones as well as royalties on sales of the therapies, if Roche proceeds the clinical development. Roche to get an exclusive license to develop and commercialize UCB0107 for AD UCB to fund and perform a POC study in …

Roche and UCB Collaborate to Develop UCB0107 for Alzheimer’s Disease 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, …

PharmaShots Weekly Snapshot (Jul 20- 24, 2020) Read More »

Insights+ Exclusive: The US FDA New Drug Approvals in June 2020

 The US FDA has approved multiple NDAs and BLAs in Jun 2020, 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 51 novel products so far in 2020, including 8 in Jun 2020. Additionally, …

Insights+ Exclusive: The US FDA New Drug Approvals in June 2020 Read More »

Pandemic and currency headwinds hurt Roche in first half

Roche has announced half-year results showing the COVID-19 pandemic affected sales of its key products, with currency headwinds also weighing on revenues. The Swiss pharma’s figures came shortly after its arch-rival Novartis conceded that it had hit similar problems as the pandemic meant fewer patients started new courses of its drugs. Four of the company’s …

Pandemic and currency headwinds hurt Roche in first half Read More »

Roche Collaborates with Jnana Therapeutics to Discover Novel Therapies to Treat Immune-Mediated and Neurological Diseases

Shots: Jnana to receive $40M upfront payment in cash and is eligible to get ~$1B as research funding, preclinical, development, and commercialization milestone along with royalties on sales of the therapies The partners will work on the discovery and preclinical development of therapies targeting key regulators of cellular metabolism to treat across immunology and neuroscience …

Roche Collaborates with Jnana Therapeutics to Discover Novel Therapies to Treat Immune-Mediated and Neurological Diseases Read More »

Roche Signs RWD Collaboration with PicnicHealth to Create Personalized Treatment for Patients with Multiple Sclerosis

Shots: The real-world evidence partnership will allow the Roche to access PicnicHealth’s set of de-identified patient records to gain insights on certain diseases and treatments The collaboration will initially focus on MS and may be extended to support Huntington’s disease (HD), paroxysmal nocturnal hemoglobinuria (PNH), and hemophilia The companies signed a multi-year collaboration that combines …

Roche Signs RWD Collaboration with PicnicHealth to Create Personalized Treatment for Patients with Multiple Sclerosis Read More »

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 …

PharmaShots Weekly Snapshot (Jul 13- 17, 2020) Read More »

Roche, PicnicHealth start RWD partnership with multiple sclerosis focus

The companies will use a combination of more than seven years of medical record data with five years of prospective data on 5,000 MS patients, including real-world outcomes data and MRI images. Other disease areas to be explored include hematology and rare diseases.

Roche pays Blueprint $675M upfront for ex-U.S. development, commercialization rights to cancer drug

Under the deal, Blueprint will additionally be eligible for more than $900M in milestone payments plus royalties for the RET inhibitor pralsetinib. The deal includes exclusive rights for Roche in ex-U.S. markets other than China and shared rights in the U.S.

Treating Pharma Data as an Asset: moving from an application centric to an information-centric organization – presented by Dr. Martin Romacker, Roche

Pharma knows there is a need for clean, reusable, FAIR data to fuel effective machine learning-driven R&D – but driving effective information and knowledge management is a long process, needing a step change where individuals learn their roles in data stewardship and reduce them to practice in a way that doesn’t constrain or impede their …

Treating Pharma Data as an Asset: moving from an application centric to an information-centric organization – presented by Dr. Martin Romacker, Roche Read More »