Category: Roche

  • 4th Treg Directed Therapies Summit 2022

    Turbocharge the Development of Best-In-Class Treg-Directed Therapies, Maximising Stability and Function to Deliver Safe, Scalable and Efficacious Therapies Globally As Biopharma turn their focus to autoimmune drug development, there has been an explosion of interest and investment into Treg directed therapies. Promising proof-of-concept data and early clinical read outs have fueled further hype, and the industry now […]

  • US vs EU: How can Europe translate home-grown innovation into biotech success?

    We have seen a boom in biotech initial public offerings over the last two years, but many of Europe’s offerings have migrated to the United States. So, what can we do to keep home-grown science on European soil? From the Pfizer/BioNTech and Oxford/AstraZeneca vaccines to GSK’s lifesaving antibody treatments, European innovation has played a crucial […]

  • Decentralised trials: beyond the pandemic

    The adoption of decentralised activities was a major factor in allowing clinical trials to continue during the early stages of the pandemic. Ben Hargreaves examines whether this adoption looks set to become a permanent feature of clinical trials moving into the future, rather than just supplying the tools to a temporary need. Decentralised clinical trials […]

  • Roche debuts smart glucose monitor for hospital use

    Roche has launched what it says is a first-of-its kind handheld glucose management device, backed up by a digital platform that aims to simplify the work of doctors and nurses as they deliver care to patients. The cobas pulse system is a point-of-care device that combines a glucose test strip reader with a touch screen […]

  • Chasing Roche, Merck unveils adjuvant lung cancer data for Keytruda

    Merck & Co’s Keytruda is the undisputed market leader in immunotherapy for non-small cell lung cancer (NSCLC), but was leapfrogged by Roche’s Tecentriq in the early-stage, adjuvant treatment setting. Now, it’s hoping to fight back with new phase 3 data. In the KEYNOTE-091 trial, Keytruda (pembrolizumab) significantly improved disease-free survival compared to placebo when given […]

  • PureTech challenges Roche’s Esbriet in head-to-head IPF trial

    Roche’s idiopathic pulmonary fibrosis (IPF) therapy Esbriet is already being squeezed by its main rival in the market, and could come under renewed pressure if another competitor from PureTech Health gets approved. PureTech is developing a modified version of the active ingredient in Esbriet (pirfenidone) that has just been shown to be less likely to […]

  • Biogen looks beyond Spinraza in SMA with Ionis deal

    Spinal muscular atrophy (SMA) therapy Spinraza has been a key earner for Biogen in recent years, but with sales now heading into reverse, the company is looking to extend its franchise. Its latest move is a $60 million upfront licensing deal with longstanding partner Ionis to exercise an option on BIIB115 (ION306), a longer-acting antisense […]

  • Blow for Novartis as ligelizumab can’t top Xolair in phase 3

    Novartis’ big-selling IgE inhibitor Xolair has been a mainstay of treatment for chronic spontaneous urticaria (CSU) for many years, but with biosimilars looming the company has been looking to follow-up ligelizumab to defend the franchise. That hope now look decidedly faint, as ligelizumab was able to match Xolair (omalizumab) but not improve on it in […]

  • Roche builds case for TIGIT combo in untreated lung cancer

    Roche’s closely-watched combination of anti-TIGIT antibody tiragolumab and PD-L1 inhibitor Tecentriq has shown long-term efficacy in an ongoing trial in lung cancer, adding to the evidence that two immunotherapies may be better than one. Like PD-L1, TIGIT is thought to act as a molecular brake that stops T cells from attacking tumours, and tiragolumab is […]

  • AI specialist Recursion nabs multibillion-dollar Roche partnership

    Roche has formed a decade-long alliance with Recursion Pharma that will focus on using machine learning and “industrialised” drug discovery to find new neuroscience and cancer drugs. The Swiss drugmaker is paying $150 million upfront to kick off the strategic-level partnership, which could cover as many as 40 programmes and could be worth “several billion […]

  • EU approves Roche’s Actemra for severe COVID-19

    The European Commission has moved swiftly to grant full approval to Roche’s Actemra/RoActemra as a treatment for severe COVID-19, clearing the drug within 24 hours of a recommendation from its advisory committee. Actemra (tocilizumab) has been approved for the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical […]

  • After Scotland says no, NICE backs Lilly’s Retsevmo for lung cancer

    Eli Lilly’s RET inhibitor Retsevmo can now be prescribed on the NHS for people with RET fusion-positive advanced non-small cell lung cancer (NSCLC) in England and Wales, within the Cancer Drugs Fund (CDF). The recommendation from health technology assessment (HTA) agency NICE comes a couple of weeks after Retsevmo (selpercatinib) was cleared for use in […]

  • ASH abstract drop backs Roche’s Polivy in first-line lymphoma

    Roche trumpeted a top-line results of the POLARIX trial of its Polivy therapy in previously-untreated B-cell lymphoma, and a first look at the data suggests it is on track for approval in what could be a highly lucrative new market. An abstract of the results published ahead of the upcoming American Society of Haematology (ASH) […]

  • Roche, Blueprint’s RET cancer drug Gavreto cleared in EU

    Roche and Blueprint Medicines have opened a second front in their rivalry with Eli Lilly in RET-mutated cancers, after getting approval for Gavreto from the European Commission. Gavreto (pralsetinib) has been cleared as a first-line treatment of people with RET fusion-positive advanced non-small cell lung cancer (NSCLC), a disease that is diagnosed in around 37,000 […]

  • NICE reaches a deal with Roche on access to oral SMA drug Evrysdi

    Roche’s oral treatment Evrysdi for the rare genetic disease spinal muscular atrophy (SMA) will be made available on the NHS in England, after NICE reached a three-year access agreement with the company. The cost-effectiveness agency had turned down Evrysdi (risdiplam) in draft guidance published in June, saying it was too expensive, but after negotiations with […]

  • Pfizer files oral COVID pill in US, signs access deal for 95 countries

    Armed with impressive new data for its oral antiviral Paxlovid, Pfizer has filed for emergency use authorisation as a COVID-19 treatment in the US – and signed a deal to allow other manufacturers to make it in some lower-income countries. Paxlovid – based on new protease inhibitor PF-07321332 and HIV drug ritonavir – was found […]

  • PharmaShots Weekly Snapshots (November 08 – 12, 2021)

    Eisai Presents Results of Lecanemab in P-IIb Study 201 Study for the Treatment of Alzheimer’s Disease at CTAD 2021 Published: Nov 12, 2021 | Tags: Eisai, Lecanemab, P-IIb, Study 201 Study, Alzheimer’s Disease, CTAD 2021 Novo Nordisk’s Wegovy (semaglutide) Receives CHMP’s Recommendation for Approval to Treat Obesity Published: Nov 12, 2021 | Tags: Novo Nordisk, […]

  • COVID antibodies from Roche, Celltrion backed for approval in EU

    The EMA’s human medicines committee has recommended approval of Roche’s Ronapreve and Celltrion’s Regkirona for use in COVID-19, the first antibody-based therapies for coronavirus to be backed for full approval in the EU. Ronapreve (casirivimab and imdevimab) – developed and distributed by Regeneron as REGN-COV in the US – has been recommended by the CHMP […]

  • PharmaShots Weekly Snapshots (November 01 – 03, 2021)

    Lonza Collaborates with Codiak to Acquire its Exosomes Manufacturing Facility in Lexington, Massachusetts (US) Published: Nov 3, 2021 | Tags: Lonza, Codiak, Acquire, Exosomes Manufacturing Facility, Lexington, Massachusetts, US Amylyx Submits NDA to the US FDA for AMX0035 to Treat Amyotrophic Lateral Sclerosis Published: Nov 3, 2021 | Tags: Amylyx, NDA, US, FDA, AMX0035, ALS […]

  • Novartis finally sells Roche stake, for almost $21 billion

    After more than 20 years, Novartis has finally decided to sell its substantial share in fellow Swiss pharma group Roche for $20.7 billion, a decent return on its original $5 billion investment. The agreement will see Novartis lose its one-third voting share stake in Roche, after agreeing to sell 53.3 million Roche bearer shares at […]

  • Roche Entered into a Clinical Trial Supply Agreement with Galecto to Evaluate GB1211 + Tecentriq (atezolizumab) in P-IIa Trial for 1L Treatment of NSCLC

    Shots: The companies collaborated to evaluate the safety, tumor shrinkage, clinical activity & immune biomarkers of Galecto’s GB1211 (galectin-3 inhibitor) + Roche’s Tecentriq (PD-L1 checkpoint inhibitor) in P-IIa trial in a ratio (1:1) in 70 patients with NSCLC. The P-IIa study is expected to start in 2022 & results are expected in mid-2023 Galecto will […]

  • Merck gets EU approval for Keytruda in triple-negative breast cancer

    Merck & Co has claimed EU approval for Keytruda in triple-negative breast cancer (TNBC), a particularly hard-to-treat form of the disease. The European Commission has cleared Keytruda (pembrolizumab) in combination with chemotherapy as a first-line treatment for locally recurrent, unresectable or metastatic TNBC involving tumours with a PD-L1 expression score of 10 or more. The […]

  • FDA clears Roche’s Susvimo implant for eye disease wet AMD

    Roche’s Genentech unit has won FDA approval for Susvimo, an implant for eyesight-robbing disease wet age-related macular degeneration (AMD) that gives patients an alternative to regular injections into the eye. Susvimo has the same active ingredient as Roche’s big-selling therapy Lucentis (ranibizumab), a VEGF inhibitor administered once a month that has been approved by the […]

  • Delta variant keeps Roche diagnostics sales sky high

    High demand for COVID-19 diagnostics driven by the delta variant has led to rocketing sales at Roche’s diagnostics division, allowing the company to raise its sales forecast for the year. Diagnostics sales rose 39% to CHF 13.3 billion ($14.4 billion) in the first nine months of the year, with the strong performance of the company’s […]

  • HLTH21: Roche, Ibex Medical Partner to Develop AI-Powered Digital Pathology Apps

    What You Should Know:  – Ibex Medical Analytics, the pioneer in AI-based cancer diagnostics, today announced that it has signed a deal with Roche, the world’s largest biotech company and global pioneer in pharmaceuticals and diagnostics. Ibex will be integrating its Galen™ platform into Roche’s uPath enterprise cloud software in order to help pathologists to […]

  • Roche scores early adjuvant lung cancer approval for Tecentriq

    Roche has claimed an earlier-than-expected FDA approval for its checkpoint inhibitor Tecentriq in non-small cell lung cancer (NSCLC), giving the drug a lead in early-stage cases that can be treated with surgery. The US regulator has cleared Tecentriq (atezolizumab) as adjuvant treatment after surgery and platinum-based chemotherapy in patients with tumours in which 1% or […]

  • Prenosis, Roche Partner to Combat Hospital Sepsis Using Precision Diagnostics

    What You Should Know:  – Prenosis Inc., a precision diagnostics company transforming clinical diagnosis with artificial intelligence, announced today the expansion of an existing partnership with Roche Diagnostics that will total close to $6 million to improve and expedite the clinical recognition of sepsis. – Building upon the collaboration that the companies started together in […]

  • Actemra shortage spills over to include Sanofi’s rival Kevzara

    Roche’s Actemra has been in high demand since its value in treating severe COVID-19 was established, leading to shortages. Now, Sanofi’s rival therapy Kevzara has also been hit by supply constraints. Sanofi said in a statement that supply of all four formats of Kevzara (sarilumab) – 150 mg or 200 mg pre-filled syringes or auto-injectors […]

  • Enhertu nabs speedy FDA review for earlier use in breast cancer

    Hard on the heels of impressive new data for Enhertu as a second-line therapy for breast cancer, AstraZeneca and Daichi Sankyo have claimed FDA breakthrough status for the drug that should shorten its review time. The new designation for Enhertu (trastuzumab deruxtecan) is based on the results of the DESTINY-Breast03 trial, which showed that the […]

  • NICE clears NHS use of Roche’s Tecentriq in bladder cancer

    NICE has recommended routine NHS access to Roche’s cancer immunotherapy Tecentriq for some bladder cancer patients, four years after it was first made available via the Cancer Drugs Fund (CDF). The PD-L1 inhibitor was initially turned down by NICE for a form of bladder cancer called urothelial carcinoma (UC), but Roche was encouraged to make […]

  • Innovaccer, Roche Partner to Develop Clinical Decision Support Solutions

    What You Should Know:  – Innovaccer Inc. the Health Cloud company, announced it has entered into a three-year collaboration with Roche to partner in the development of innovative clinical decision support solutions on the InnovaccerⓇ Health Cloud for the U.S. market. – As part of the strategic collaboration, the Innovaccer Health Cloud and its core […]

  • PharmaShots Weekly Snapshots (September 20 – 24, 2021)

    Everest’s SPR206 Receives the NMPA’s IND Approval for the Treatment of MDR Gram-Negative Bacterial Infections Published: Sept 24, 2021 | Tags: Everest, SPR206, NMPA, IND, Approval, MDR Gram-Negative Bacterial Infections GE Healthcare to Acquire BK Medical for ~ $1.45B Published: Sept 24, 2021 | Tags: GE Healthcare, Acquire, BK Medical, ~ $1.45B Roche Presents Results […]

  • Roche builds evidence for Evrysdi’s benefits younger SMA patients

    Roche has highlighted new data with its oral treatment for spinal muscular atrophy (SMA) – Evrysdi – showing its benefits when given to pre-symptomatic babies with the rare disease. The updated results come from the open-label RAINBOWFISH study, which investigate the effects of Evrysdi (risdiplam) in children from birth to six weeks who had yet […]

  • 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 […]

  • 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: 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 […]

  • 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 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 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 […]

  • 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, […]

  • 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: […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 – […]

  • 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 | […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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. […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 + […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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% […]

  • 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’ 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 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 […]

  • 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)

    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, […]

  • 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

    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 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 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 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 […]

  • 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: […]

  • 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 […]

  • 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 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 […]

  • 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, […]

  • 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 […]

  • 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: […]

  • 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⍺ […]

  • 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 | […]

  • 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 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 […]

  • 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, […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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, […]

  • 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’ 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 […]

  • 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 […]

  • 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 […]

  • 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) […]

  • 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 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 […]

  • 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 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, […]

  • 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 […]

  • 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, […]

  • 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. […]

  • 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 […]

  • 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 […]

  • 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, […]

  • 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 […]

  • 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 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

    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 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 […]

  • 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, […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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, […]

  • 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 […]

  • 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), […]

  • 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 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 […]

  • 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 […]

  • 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, […]

  • 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 […]

  • 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 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 […]

  • 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 […]

  • 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 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 […]

  • 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 […]

  • 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 […]

  • AI drug-discovery firm lands first partnership

    The deal with Roche subsidiary Genentech is likely not the last for Genesis Therapeutics, which is based on AI research undertaken at Stanford. Such partnerships are potentially lucrative for drug-discovery startups.

  • 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 […]

  • 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, […]

  • 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 […]

  • 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 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

    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 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 […]

  • 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, […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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, […]

  • 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 […]

  • 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. […]

  • 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 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’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 […]

  • 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, […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 + 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 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’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 […]

  • 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 […]

  • 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 […]